Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT04393493
Status:
COMPLETED
Last Update Posted:
2020-09-14
First Post:
2017-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Effect in Renal Function on Patients With Type 1 Cardiorenal Syndrome Treated With Two Strategies of Furosemide.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059347', 'term': 'Cardio-Renal Syndrome'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002752', 'term': 'Chlorthalidone'}, {'id': 'D013148', 'term': 'Spironolactone'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D001577', 'term': 'Benzophenones'}, {'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D007094', 'term': 'Imides'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jonarchi_10@hotmail.com', 'phone': '3313299609', 'title': 'Dr Jonathan Chavez Iñiguez', 'organization': 'hospital civil de guadalajara'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality was assessed at hospitalisation and during follow-up which lasted an average of 182 days. Serious adverse events and other adverse events were assessed during the 4 days that the intervention lasted.', 'description': 'We assessed serious adverse events and other adverse events through daily clinical evaluation by one member of the nephrology team in charge and daily laboratory testing for serum creatinine, urea, glucose, sodium, potassium, chlorine, calcium, phosphorous, arterial or venous blood gas, and complete blood count.\n\nAll cause mortality during follow-up was assessed through monthly phone calls to patients and/or searching at Hospital electronic records.', 'eventGroups': [{'id': 'EG000', 'title': 'Stepped Furosemide', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally continuous infused furosemide as follows:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution\n* Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution\n* Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution\n* Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 36, 'seriousNumAtRisk': 40, 'deathsNumAffected': 13, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Diuretics Combined', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 35, 'seriousNumAtRisk': 40, 'deathsNumAffected': 16, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Hypokalemia', 'notes': 'Any serum potassium \\< 3.5 mEq/L during the intervention (4 days)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyponatremia', 'notes': 'Any serum sodium \\< 3.5 mEq/L during the intervention (4 days)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolic alkalosis', 'notes': 'Any venous or arterial blood gas bicarbonate levels \\>28 mEq/L during the intervention (4 days)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hypotension', 'notes': 'Any systolic blood pressure \\< 90mmHg and/or mean arterial pressure \\<65 mmHg', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Renal Function Recovery Defined as a Return to Individual Baseline Serum Creatinine Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stepped Furosemide', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution\n* Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution\n* Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution\n* Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution'}, {'id': 'OG001', 'title': 'Diuretics Combined', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 96 hours after intervention started', 'description': "Comparing patient's baseline serum creatinine (previous serum creatinine of 3 months ago and up to a year ago) with creatinine measurements every 24 hours during intervention (4 days)", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in 24 Hour Urine Output at 96 Hours After Intervention Started From 24 Hour Urine Output One Day Before Intervention Initiation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stepped Furosemide', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally continuous infused furosemide as follows:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution\n* Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution\n* Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution\n* Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution'}, {'id': 'OG001', 'title': 'Diuretics Combined', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.'}], 'classes': [{'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000', 'lowerLimit': '-350', 'upperLimit': '1312'}, {'value': '200', 'groupId': 'OG001', 'lowerLimit': '-625', 'upperLimit': '363'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours after intervention started', 'description': 'Urine output was collected through an urinary catheter and measured and registered by a nurse. The sum of these registrations from 7 am from one day to 7 am of the next day was considered the 24 hour urinary output', 'unitOfMeasure': 'ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Serum Creatinine at Day One of Intervention From Serum Creatinine at 96 Hrs After Intervention Started', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stepped Furosemide', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally continuous infused furosemide as follows:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution\n* Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution\n* Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution\n* Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution'}, {'id': 'OG001', 'title': 'Diuretics Combined', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '0.6'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '-0.02', 'upperLimit': '0.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours after intervention started', 'description': 'Calculated as serum creatinine at day one minus serum creatinine at 96 hrs after intervention started', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'An Elevation of at Least 0.3 mg/dl of Serum Creatinine From Day One of Intervention Compared With Serum Creatinine at 96hrs After Intervention Started', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stepped Furosemide', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally continuous infused furosemide as follows:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution\n* Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution\n* Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution\n* Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution'}, {'id': 'OG001', 'title': 'Diuretics Combined', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '96 hours after intervention started', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients without serum creatinine measured at 96hrs were excluded from this analysis.'}, {'type': 'SECONDARY', 'title': 'In Hospital Mortality Defined as Number of Dead Patients From Day One of Intervention and Before Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stepped Furosemide', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally continuous infused furosemide as follows:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution\n* Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution\n* Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution\n* Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution'}, {'id': 'OG001', 'title': 'Diuretics Combined', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From day one of intervention up to discharge, an average of 1 week', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mortality During Follow up Defined as Number of Dead Patients After Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stepped Furosemide', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally continuous infused furosemide as follows:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution\n* Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution\n* Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution\n* Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution'}, {'id': 'OG001', 'title': 'Diuretics Combined', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From day one after discharge up to an average of 161 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Dyspnea Improvement as Referred by the Patient or Reduction in Supplementary Oxygen Requirements at 96 Hours After Intervention Started', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stepped Furosemide', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally continuous infused furosemide as follows:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution\n* Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution\n* Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution\n* Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution'}, {'id': 'OG001', 'title': 'Diuretics Combined', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 96 hours after intervention started', 'description': 'Dyspnea improvement was referred by the patient as the clinician asked them "do you feel more or less difficult to breathe?" or if the liters per minute or the fraction of inspired supplementary oxygen necessary to maintain an oxygen saturation \\>90% were diminished', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Dyspnea Improvement as Referred by the Patient or Reduction in Supplementary Oxygen Requirements Before Day 3 of Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stepped Furosemide', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally continuous infused furosemide as follows:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution\n* Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution\n* Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution\n* Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution'}, {'id': 'OG001', 'title': 'Diuretics Combined', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 3 days after intervention started', 'description': 'Dyspnea improvement was referred by the patient as the clinician asked them "do you feel more or less difficult to breathe?" or if the liters per minute or the fraction of inspired supplementary oxygen necessary maintain an oxygen saturation \\>90% were diminished', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Days From the Beginning of the Intervention Until Patients Referred Dyspnea Improvement or a Reduction in Supplementary Oxygen Requirements Was Made.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stepped Furosemide', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally continuous infused furosemide as follows:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution\n* Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution\n* Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution\n* Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution'}, {'id': 'OG001', 'title': 'Diuretics Combined', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '4'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 4 days after intervention started', 'description': 'Dyspnea improvement was referred by the patient as the clinician asked them "do you feel more or less difficult to breathe?" or if the liters per minute or the fraction of inspired supplementary oxygen necessary maintain an oxygen saturation \\>90% were diminished', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients That Required Renal Replacement Therapy of Any Type During Intervention (4 Days).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stepped Furosemide', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally continuous infused furosemide as follows:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution\n* Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution\n* Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution\n* Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution'}, {'id': 'OG001', 'title': 'Diuretics Combined', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 96 hours after intervention started', 'description': 'The requirement of renal replacement therapy was assessed by the nephrology team in charge', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Serum Copeptin Levels at Day One of Intervention From Serum Copeptin Levels Measured at 96 Hrs After Intervention Started.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stepped Furosemide', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally continuous infused furosemide as follows:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution\n* Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution\n* Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution\n* Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution'}, {'id': 'OG001', 'title': 'Diuretics Combined', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '-20', 'upperLimit': '21'}, {'value': '-16', 'groupId': 'OG001', 'lowerLimit': '-26', 'upperLimit': '13'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours after intervention started', 'description': 'Calculated as serum copeptin levels at day one minus serum copeptin levels measured at 96 hrs after intervention started', 'unitOfMeasure': 'ng/dl', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients without the copeptin measurements made at day one and/or at 96hrs were excluded from this analysis'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Serum Brain Natriuretic Peptide Levels at Baseline From Serum Brain Natriuretic Peptide Levels at 96 Hours After Intervention Started', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stepped Furosemide', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally continuous infused furosemide as follows:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution\n* Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution\n* Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution\n* Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution'}, {'id': 'OG001', 'title': 'Diuretics Combined', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1344', 'spread': '1041', 'groupId': 'OG000'}, {'value': '-1378', 'spread': '1904', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours after intervention started', 'description': 'Baseline levels were defined as the measurement at hospital admission. Calculated as serum brain natriuretic peptide levels at baseline minus serum brain natriuretic peptide levels at 96 hours after intervention started', 'unitOfMeasure': 'ng/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients without baseline brain natriuretic peptide measurements and/or without measurements at 96hrs were excluded from this analysis'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Patients That Achieved >30% Reduction in Brain Natriuretic Compared With Baseline Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stepped Furosemide', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally continuous infused furosemide as follows:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution\n* Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution\n* Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution\n* Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution'}, {'id': 'OG001', 'title': 'Diuretics Combined', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 96 hours after intervention started', 'description': 'Baseline levels were defined as the measurement at hospital admission', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients without baseline brain natriuretic peptide measurements and/or without measurements at 96hrs were excluded from this analysis'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Patients Whose Interventions Were Stopped Because Clinical Improvement Was Achieved Before 96 Hours as Assessed by de Clinical Judgement of the Medical Team in Charge.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stepped Furosemide', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally continuous infused furosemide as follows:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution\n* Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution\n* Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution\n* Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution'}, {'id': 'OG001', 'title': 'Diuretics Combined', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the beginning of intervention and before 96 hours after that', 'description': 'Clinical improvement was referred as remission of symptoms with achievement of 24 hour urine output equal or greater than 3000 milliliters', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Serum Urea Levels Measured at Day One of Intervention From Serum Urea Levels Measured at 96 Hrs After Intervention Started.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stepped Furosemide', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally continuous infused furosemide as follows:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution\n* Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution\n* Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution\n* Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution'}, {'id': 'OG001', 'title': 'Diuretics Combined', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '-11', 'upperLimit': '37'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '45'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours after intervention started', 'description': 'Calculated as serum urea levels at day one of intervention minus serum urea levels at 96 hrs after intervention started.', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Serum Sodium Levels Measured at Day One of Intervention From Serum Sodium Levels Measured at 96 Hrs After Intervention Started.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stepped Furosemide', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally continuous infused furosemide as follows:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution\n* Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution\n* Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution\n* Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution'}, {'id': 'OG001', 'title': 'Diuretics Combined', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '4.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours after intervention started', 'description': 'Calculated as serum sodium levels at day one of intervention minus serum sodium levels at 96 hrs after intervention started.', 'unitOfMeasure': 'mEq/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Serum Potassium Levels Measured at Day One of Intervention From Serum Potassium Levels Measured at 96 Hrs After Intervention Started.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stepped Furosemide', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally continuous infused furosemide as follows:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution\n* Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution\n* Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution\n* Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution'}, {'id': 'OG001', 'title': 'Diuretics Combined', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours after intervention started', 'description': 'Calculated as serum potassium levels at day one of intervention minus serum potassium levels at 96 hrs after intervention started.', 'unitOfMeasure': 'mEq/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Serum Chloride Levels Measured at Day One of Intervention From Serum Chloride Levels Measured at 96 Hrs After Intervention Started.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stepped Furosemide', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally continuous infused furosemide as follows:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution\n* Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution\n* Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution\n* Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution'}, {'id': 'OG001', 'title': 'Diuretics Combined', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '4.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours after intervention started', 'description': 'Calculated as serum chloride levels at day one of intervention minus serum chloride levels at 96 hrs after intervention started.', 'unitOfMeasure': 'mEq/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Serum Magnesium Levels Measured at Day One of Intervention From Serum Magnesium Levels Measured at 96 Hrs After Intervention Started.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stepped Furosemide', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally continuous infused furosemide as follows:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution\n* Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution\n* Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution\n* Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution'}, {'id': 'OG001', 'title': 'Diuretics Combined', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.07', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours after intervention started', 'description': 'Calculated as serum magnesium levels at day one of intervention minus serum magnesium levels at 96 hrs after intervention started.', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Serum Calcium Levels Measured at Day One of Intervention From Serum Calcium Levels Measured at 96 Hrs After Intervention Started.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stepped Furosemide', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally continuous infused furosemide as follows:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution\n* Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution\n* Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution\n* Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution'}, {'id': 'OG001', 'title': 'Diuretics Combined', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.15', 'groupId': 'OG000', 'lowerLimit': '-0.4', 'upperLimit': '0.6'}, {'value': '-0.05', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '0.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours after intervention started', 'description': 'Calculated as serum calcium levels at day one of intervention minus serum calcium levels at 96 hrs after intervention started.', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Serum pH Value Measured at Day One of Intervention From Serum pH Value Measured at 96 Hrs After Intervention Started.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stepped Furosemide', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally continuous infused furosemide as follows:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution\n* Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution\n* Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution\n* Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution'}, {'id': 'OG001', 'title': 'Diuretics Combined', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours after intervention started', 'description': 'Calculated as serum pH value at day one of intervention minus serum pH value at 96 hrs after intervention started.', 'unitOfMeasure': 'units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Serum Bicarbonate Levels Measured at Day One of Intervention From Serum Bicarbonate Levels Measured at 96 Hrs After Intervention Started.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stepped Furosemide', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally continuous infused furosemide as follows:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution\n* Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution\n* Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution\n* Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution'}, {'id': 'OG001', 'title': 'Diuretics Combined', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg orally every 24 hours + Spironolactone 25mg orally every 24 hrs.\n* Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg orally every 24 hours + Spironolactone 50mg orally every 24 hrs.\n* Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg orally every 24 hours + Spironolactone 50 orally every 24 hrs.\n* Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg orally every 24 hours + Spironolactone 50mg orally every 24 hrs.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '5.5'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '4.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours after intervention started', 'description': 'Calculated as serum bicarbonate levels at day one of intervention minus bicarbonate levels at 96 hrs after intervention started.', 'unitOfMeasure': 'mEq/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Serum Partial Pressure of Carbon Dioxide Measured at Day One of Intervention From Serum Partial Pressure of Carbon Dioxide Measured at 96 Hrs After Intervention Started.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stepped Furosemide', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally continuous infused furosemide as follows:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution\n* Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution\n* Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution\n* Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution'}, {'id': 'OG001', 'title': 'Diuretics Combined', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '6.7'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '-1.5', 'upperLimit': '6'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours after intervention started', 'description': 'Calculated as serum partial pressure of carbon dioxide at day one of intervention minus serum partial pressure of carbon dioxide at 96 hrs after intervention started.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Serum Lactate Levels Measured at Day One of Intervention From Serum Lactate Levels Measured at 96 Hrs After Intervention Started.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stepped Furosemide', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally continuous infused furosemide as follows:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution\n* Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution\n* Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution\n* Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution'}, {'id': 'OG001', 'title': 'Diuretics Combined', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '0.4'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '0.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours after intervention started', 'description': 'Calculated as serum lactate levels at day one of intervention minus serum lactate levels at 96 hrs after intervention started.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stepped Furosemide', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally continuous infused furosemide as follows:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution\n* Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution\n* Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution\n* Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution'}, {'id': 'FG001', 'title': 'Diuretics Combined', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg orally every 24 hours + Spironolactone 25mg orally every 24 hrs.\n* Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg orally every 24 hours + Spironolactone 25mg orally every 24 hrs.\n* Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg orally every 24 hours + Spironolactone 25mg orally every 24 hrs.\n* Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg orally every 24 hours + Spironolactone 25mg orally every 24 hrs.'}], 'periods': [{'title': 'Follow up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'First 4 Days of Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Early improvement', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'We screened all consecutive patients admitted for acute decompensated heart failure (ADHF) and acute kidney injury (AKI) who were evaluated by the Nephrology service at the Hospital Civil de Guadalajara Fray Antonio Alcalde, an University Hospital, from July 2017 to February 2020.', 'preAssignmentDetails': 'Of 168 patients assessed for eligibility, 80 met inclusion criteria and were randomized to treatment'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Stepped Furosemide', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution\n* Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution\n* Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution\n* Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution'}, {'id': 'BG001', 'title': 'Diuretics Combined', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '58', 'spread': '14.5', 'groupId': 'BG000'}, {'value': '59', 'spread': '14.6', 'groupId': 'BG001'}, {'value': '59', 'spread': '14.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Hospital medical record of diabetes diagnosis or current use of antidiabetic drugs', 'unitOfMeasure': 'Participants', 'populationDescription': 'Patients without the information required to assess this variable where excluded from the calculation'}, {'title': 'Hypertension', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Hospital medical record of hypertension diagnosis or current use of antihypertensive drugs', 'unitOfMeasure': 'Participants', 'populationDescription': 'Patients without the information required to assess this variable where excluded from the calculation'}, {'title': 'Baseline serum creatinine', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'BG000', 'lowerLimit': '2.2', 'upperLimit': '4.7'}, {'value': '2.8', 'groupId': 'BG001', 'lowerLimit': '2.1', 'upperLimit': '4'}, {'value': '2.9', 'groupId': 'BG002', 'lowerLimit': '2.2', 'upperLimit': '4.5'}]}]}], 'paramType': 'MEAN', 'description': 'Recorded serum creatinine form at least 3 months ago and up to one year ago', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Chronic kidney disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Medical record of chronic kidney disease or as defined by KDIGO guidelines.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Patients without the information required to assess this variable where excluded from the calculation'}, {'title': 'Baseline estimated glomerular filtration rate', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '40'}, {'value': '28', 'groupId': 'BG001', 'lowerLimit': '16', 'upperLimit': '58'}, {'value': '28', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '49'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ml/min/1.73m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Acute myocardial infarction', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Diagnosis of acute myocardial infarction by the cardiology service at admission.\n\nOur Hospital uses troponin levels, electrocardiographic changes and coronary angiography', 'unitOfMeasure': 'Participants', 'populationDescription': 'Patients without the information required to assess this variable where excluded from the calculation'}, {'title': 'Chronic heart failure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Medical record of chronic heart failure diagnosis or previous echocardiographic study showing reduced left ventricular ejection fraction (\\<40%) or diastolic disfunction (elevated filling pressures).', 'unitOfMeasure': 'Participants', 'populationDescription': 'Patients without the information required to assess this variable where excluded from the calculation'}, {'title': 'Hypothyroidism', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Medical record of hypothyroidism diagnosis or diagnosed at hospitalisation with thyroid stimulating hormone and free T4 measures.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Patients without the information required to assess this variable where excluded from the calculation'}, {'title': 'Arrythmia', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Medical record of any type of arrythmia or diagnosed at admission.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Patients without the information required to assess this variable where excluded from the calculation'}, {'title': 'Current smoker', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Patient self reported current smoking', 'unitOfMeasure': 'Participants', 'populationDescription': 'Patients without the information required to assess this variable where excluded from the calculation'}, {'title': 'Heart rate', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000', 'lowerLimit': '80', 'upperLimit': '99'}, {'value': '82', 'groupId': 'BG001', 'lowerLimit': '70.5', 'upperLimit': '94'}, {'value': '85', 'groupId': 'BG002', 'lowerLimit': '72', 'upperLimit': '98'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Oxygen saturation', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '95', 'groupId': 'BG000', 'lowerLimit': '92', 'upperLimit': '96'}, {'value': '94', 'groupId': 'BG001', 'lowerLimit': '92', 'upperLimit': '96'}, {'value': '94', 'groupId': 'BG002', 'lowerLimit': '92', 'upperLimit': '96'}]}]}], 'paramType': 'MEAN', 'description': 'Individual average of measurements of one day before intervention started. Measurements made with pulse oximeter', 'unitOfMeasure': 'percentage', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Systolic blood pressure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '126', 'spread': '23', 'groupId': 'BG000'}, {'value': '134', 'spread': '22', 'groupId': 'BG001'}, {'value': '130', 'spread': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Individual average of measurements of one day before intervention started. Measurements made with a manual aneroid sphygmomanometer', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic blood pressure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '74', 'spread': '12', 'groupId': 'BG000'}, {'value': '77', 'spread': '14', 'groupId': 'BG001'}, {'value': '75', 'spread': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Individual average of measurements of one day before intervention started. Measurements made with a manual aneroid sphygmomanometer', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Uric acid', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'BG000', 'lowerLimit': '8.1', 'upperLimit': '9.5'}, {'value': '9.1', 'groupId': 'BG001', 'lowerLimit': '8.1', 'upperLimit': '11.4'}, {'value': '8.6', 'groupId': 'BG002', 'lowerLimit': '8.1', 'upperLimit': '10.3'}]}]}], 'paramType': 'MEAN', 'description': 'First measurement during hospitalisation or most recent previous levels from up to 3 months ago.', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Patients without the information required to assess this variable where excluded from the calculation'}, {'title': 'Presence of proteinuria in dipstick urinalysis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Measured with the first dipstick urinalysis during hospitalisation', 'unitOfMeasure': 'Participants', 'populationDescription': 'Patients without the information required to assess this variable where excluded from the calculation'}, {'title': 'Presence of hematuria in dipstick urinalysis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Measured with the first dipstick urinalysis during hospitalisation', 'unitOfMeasure': 'Participants', 'populationDescription': 'Patients without the information required to assess this variable where excluded from the calculation'}, {'title': 'Serum brain natriuretic peptide', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2501', 'spread': '1669', 'groupId': 'BG000'}, {'value': '2718', 'spread': '1836', 'groupId': 'BG001'}, {'value': '2631', 'spread': '1713', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Brain natriuretic peptide measured at admission as part of evaluation of acute heart failure', 'unitOfMeasure': 'ng/dl', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Patients without the information required to assess this variable where excluded from the calculation'}, {'title': 'Serum copeptin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000', 'lowerLimit': '29', 'upperLimit': '207'}, {'value': '72', 'groupId': 'BG001', 'lowerLimit': '49', 'upperLimit': '115'}, {'value': '75', 'groupId': 'BG002', 'lowerLimit': '48', 'upperLimit': '169'}]}]}], 'paramType': 'MEAN', 'description': 'Levels measured at first day of intervention', 'unitOfMeasure': 'ng/dl', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Patients without the information required to assess this variable where excluded from the calculation'}, {'title': 'Use of antibiotics at admission', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Antibiotic prescription at admission or at some point during hospitalisation', 'unitOfMeasure': 'Participants', 'populationDescription': 'Patients without the information required to assess this variable where excluded from the calculation'}, {'title': 'Blood transfusion during hospitalisation', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Requirement of blood transfusion at admission or at some point during hospitalisation.\n\nThe indication was assessed by the clinical team in charge', 'unitOfMeasure': 'Participants', 'populationDescription': 'Patients without the information required to assess this variable where excluded from the calculation'}, {'title': 'Use of vasopressor drugs', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Prescription of vasopressor drugs at admission or during hospitalisation.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Patients without the information required to assess this variable where excluded from the calculation'}, {'title': 'Use of inotropic drugs', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Prescription of inotropic drugs at admission or during hospitalization\n\n.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Patients without the information required to assess this variable where excluded from the calculation'}, {'title': '24 hr urinary volume before intervention', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1278.93', 'groupId': 'BG000', 'lowerLimit': '800', 'upperLimit': '1475'}, {'value': '1235.38', 'groupId': 'BG001', 'lowerLimit': '762', 'upperLimit': '1400'}, {'value': '1266.57', 'groupId': 'BG002', 'lowerLimit': '775', 'upperLimit': '1450'}]}]}], 'paramType': 'MEAN', 'description': '24 hour urine volume measured one day before intervention started. Measurement was made by a nurse and the urine recollection was made through an urine catheter bag', 'unitOfMeasure': 'ml/day', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Use of normal saline as reanimation fluid', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Prescription of intravenous normal saline as reanimation or hydration fluid at admission or during intervention', 'unitOfMeasure': 'Participants'}, {'title': 'Use of Hartmann solution as reanimation fluid', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Prescription of intravenous Hartmann solution as reanimation or hydration fluid at admission or during intervention', 'unitOfMeasure': 'Participants', 'populationDescription': 'Patients without the information required to assess this variable where excluded from the calculation'}, {'title': 'Previous use of diuretics', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Patient self report of previous use of any type of diuretic drug in the last 3 months', 'unitOfMeasure': 'Participants'}, {'title': 'Admission to internal medicine service', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Patients admitted from emergency department by the internal medicine service', 'unitOfMeasure': 'Participants'}, {'title': 'Admission to cardiology service', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Patients admitted from emergency department by the cardiology service', 'unitOfMeasure': 'Participants'}, {'title': 'Admission to intensive care unit', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Patients admitted from emergency department by the intensive care unit service', 'unitOfMeasure': 'Participants'}, {'title': 'Admission to surgical service', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Patients admitted from emergency department by a surgical service', 'unitOfMeasure': 'Participants'}, {'title': 'Admission to other hospital service', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Admission to other speciality service than the previously specified', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-17', 'size': 204647, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-08-21T20:54', 'hasProtocol': True}, {'date': '2020-07-17', 'size': 139129, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-08-21T20:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double-blind clinical trial'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Its a randomized, controlled, phase II, 2-arm, double-blind clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-21', 'studyFirstSubmitDate': '2017-08-22', 'resultsFirstSubmitDate': '2020-07-27', 'studyFirstSubmitQcDate': '2020-05-16', 'lastUpdatePostDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-21', 'studyFirstPostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Serum Copeptin Levels at Day One of Intervention From Serum Copeptin Levels Measured at 96 Hrs After Intervention Started.', 'timeFrame': '96 hours after intervention started', 'description': 'Calculated as serum copeptin levels at day one minus serum copeptin levels measured at 96 hrs after intervention started'}, {'measure': 'Change in Serum Brain Natriuretic Peptide Levels at Baseline From Serum Brain Natriuretic Peptide Levels at 96 Hours After Intervention Started', 'timeFrame': '96 hours after intervention started', 'description': 'Baseline levels were defined as the measurement at hospital admission. Calculated as serum brain natriuretic peptide levels at baseline minus serum brain natriuretic peptide levels at 96 hours after intervention started'}, {'measure': 'Number of Patients That Achieved >30% Reduction in Brain Natriuretic Compared With Baseline Levels', 'timeFrame': 'Up to 96 hours after intervention started', 'description': 'Baseline levels were defined as the measurement at hospital admission'}, {'measure': 'Number of Patients Whose Interventions Were Stopped Because Clinical Improvement Was Achieved Before 96 Hours as Assessed by de Clinical Judgement of the Medical Team in Charge.', 'timeFrame': 'From the beginning of intervention and before 96 hours after that', 'description': 'Clinical improvement was referred as remission of symptoms with achievement of 24 hour urine output equal or greater than 3000 milliliters'}, {'measure': 'Change in Serum Urea Levels Measured at Day One of Intervention From Serum Urea Levels Measured at 96 Hrs After Intervention Started.', 'timeFrame': '96 hours after intervention started', 'description': 'Calculated as serum urea levels at day one of intervention minus serum urea levels at 96 hrs after intervention started.'}, {'measure': 'Change in Serum Sodium Levels Measured at Day One of Intervention From Serum Sodium Levels Measured at 96 Hrs After Intervention Started.', 'timeFrame': '96 hours after intervention started', 'description': 'Calculated as serum sodium levels at day one of intervention minus serum sodium levels at 96 hrs after intervention started.'}, {'measure': 'Change in Serum Potassium Levels Measured at Day One of Intervention From Serum Potassium Levels Measured at 96 Hrs After Intervention Started.', 'timeFrame': '96 hours after intervention started', 'description': 'Calculated as serum potassium levels at day one of intervention minus serum potassium levels at 96 hrs after intervention started.'}, {'measure': 'Change in Serum Chloride Levels Measured at Day One of Intervention From Serum Chloride Levels Measured at 96 Hrs After Intervention Started.', 'timeFrame': '96 hours after intervention started', 'description': 'Calculated as serum chloride levels at day one of intervention minus serum chloride levels at 96 hrs after intervention started.'}, {'measure': 'Change in Serum Magnesium Levels Measured at Day One of Intervention From Serum Magnesium Levels Measured at 96 Hrs After Intervention Started.', 'timeFrame': '96 hours after intervention started', 'description': 'Calculated as serum magnesium levels at day one of intervention minus serum magnesium levels at 96 hrs after intervention started.'}, {'measure': 'Change in Serum Calcium Levels Measured at Day One of Intervention From Serum Calcium Levels Measured at 96 Hrs After Intervention Started.', 'timeFrame': '96 hours after intervention started', 'description': 'Calculated as serum calcium levels at day one of intervention minus serum calcium levels at 96 hrs after intervention started.'}, {'measure': 'Change in Serum pH Value Measured at Day One of Intervention From Serum pH Value Measured at 96 Hrs After Intervention Started.', 'timeFrame': '96 hours after intervention started', 'description': 'Calculated as serum pH value at day one of intervention minus serum pH value at 96 hrs after intervention started.'}, {'measure': 'Change in Serum Bicarbonate Levels Measured at Day One of Intervention From Serum Bicarbonate Levels Measured at 96 Hrs After Intervention Started.', 'timeFrame': '96 hours after intervention started', 'description': 'Calculated as serum bicarbonate levels at day one of intervention minus bicarbonate levels at 96 hrs after intervention started.'}, {'measure': 'Change in Serum Partial Pressure of Carbon Dioxide Measured at Day One of Intervention From Serum Partial Pressure of Carbon Dioxide Measured at 96 Hrs After Intervention Started.', 'timeFrame': '96 hours after intervention started', 'description': 'Calculated as serum partial pressure of carbon dioxide at day one of intervention minus serum partial pressure of carbon dioxide at 96 hrs after intervention started.'}, {'measure': 'Change in Serum Lactate Levels Measured at Day One of Intervention From Serum Lactate Levels Measured at 96 Hrs After Intervention Started.', 'timeFrame': '96 hours after intervention started', 'description': 'Calculated as serum lactate levels at day one of intervention minus serum lactate levels at 96 hrs after intervention started.'}], 'primaryOutcomes': [{'measure': 'Number of Participants With Renal Function Recovery Defined as a Return to Individual Baseline Serum Creatinine Values', 'timeFrame': 'Up to 96 hours after intervention started', 'description': "Comparing patient's baseline serum creatinine (previous serum creatinine of 3 months ago and up to a year ago) with creatinine measurements every 24 hours during intervention (4 days)"}], 'secondaryOutcomes': [{'measure': 'Change in 24 Hour Urine Output at 96 Hours After Intervention Started From 24 Hour Urine Output One Day Before Intervention Initiation)', 'timeFrame': '96 hours after intervention started', 'description': 'Urine output was collected through an urinary catheter and measured and registered by a nurse. The sum of these registrations from 7 am from one day to 7 am of the next day was considered the 24 hour urinary output'}, {'measure': 'Change in Serum Creatinine at Day One of Intervention From Serum Creatinine at 96 Hrs After Intervention Started', 'timeFrame': '96 hours after intervention started', 'description': 'Calculated as serum creatinine at day one minus serum creatinine at 96 hrs after intervention started'}, {'measure': 'An Elevation of at Least 0.3 mg/dl of Serum Creatinine From Day One of Intervention Compared With Serum Creatinine at 96hrs After Intervention Started', 'timeFrame': '96 hours after intervention started'}, {'measure': 'In Hospital Mortality Defined as Number of Dead Patients From Day One of Intervention and Before Discharge', 'timeFrame': 'From day one of intervention up to discharge, an average of 1 week'}, {'measure': 'Mortality During Follow up Defined as Number of Dead Patients After Discharge', 'timeFrame': 'From day one after discharge up to an average of 161 days'}, {'measure': 'Number of Patients With Dyspnea Improvement as Referred by the Patient or Reduction in Supplementary Oxygen Requirements at 96 Hours After Intervention Started', 'timeFrame': 'Up to 96 hours after intervention started', 'description': 'Dyspnea improvement was referred by the patient as the clinician asked them "do you feel more or less difficult to breathe?" or if the liters per minute or the fraction of inspired supplementary oxygen necessary to maintain an oxygen saturation \\>90% were diminished'}, {'measure': 'Number of Patients With Dyspnea Improvement as Referred by the Patient or Reduction in Supplementary Oxygen Requirements Before Day 3 of Intervention', 'timeFrame': 'Up to 3 days after intervention started', 'description': 'Dyspnea improvement was referred by the patient as the clinician asked them "do you feel more or less difficult to breathe?" or if the liters per minute or the fraction of inspired supplementary oxygen necessary maintain an oxygen saturation \\>90% were diminished'}, {'measure': 'Number of Days From the Beginning of the Intervention Until Patients Referred Dyspnea Improvement or a Reduction in Supplementary Oxygen Requirements Was Made.', 'timeFrame': 'Up to 4 days after intervention started', 'description': 'Dyspnea improvement was referred by the patient as the clinician asked them "do you feel more or less difficult to breathe?" or if the liters per minute or the fraction of inspired supplementary oxygen necessary maintain an oxygen saturation \\>90% were diminished'}, {'measure': 'Number of Patients That Required Renal Replacement Therapy of Any Type During Intervention (4 Days).', 'timeFrame': 'Up to 96 hours after intervention started', 'description': 'The requirement of renal replacement therapy was assessed by the nephrology team in charge'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiorenal Syndrome']}, 'referencesModule': {'references': [{'pmid': '34979962', 'type': 'DERIVED', 'citation': 'Chavez-Iniguez JS, Ibarra-Estrada M, Sanchez-Villaseca S, Romero-Gonzalez G, Font-Yanez JJ, De la Torre-Quiroga A, de Quevedo AA, Romero-Munoz A, Maggiani-Aguilera P, Chavez-Alonso G, Gomez-Fregoso J, Garcia-Garcia G. The Effect in Renal Function and Vascular Decongestion in Type 1 Cardiorenal Syndrome Treated with Two Strategies of Diuretics, a Pilot Randomized Trial. BMC Nephrol. 2022 Jan 3;23(1):3. doi: 10.1186/s12882-021-02637-y.'}]}, 'descriptionModule': {'briefSummary': 'In double-blind clinical trial, determine renal recovery with two different furosemide strategies in patients with type 1 cardiorenal syndrome.', 'detailedDescription': 'In a patient with type 1 cardiorenal syndrome, we tried to compare two Furosemide strategies: both with a morning bolus, and randomized in two groups:\n\nGroup A: Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution\n* Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution\n* Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution\n* Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution\n\nGroup B: Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n\nution + Chlortalidone 50mg VO every 24 hours + Spironolactone 25mg VO every 24 hrs.\n\nWith the primary objective of improving renal function measured by serum creatinine, as secondary objectives the efficacy in vascular decongestion and electrolyte alterations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Comply with both clinical diagnosis of acute kidney injury by serum creatinine according to the Kidney Disease Improving Global Outcomes (KDIGO) 2012 guidelines and acute decompensate heart failure as clinical assessed by the clinical team in charge.\n* Have agreed and signed informed consent\n\nExclusion Criteria:\n\n* Patient in chronic dialysis either peritoneal dialysis or hemodialysis.\n* History of being a renal transplant recipient\n* History of acute kidney injury according to the KDIGO 2012 guidelines and / or renal replacement therapy in the last 3 months\n* Pregnancy\n* Impossibility to administer medication by the oral route'}, 'identificationModule': {'nctId': 'NCT04393493', 'briefTitle': 'The Effect in Renal Function on Patients With Type 1 Cardiorenal Syndrome Treated With Two Strategies of Furosemide.', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Civil de Guadalajara'}, 'officialTitle': 'The Effect in Renal Function on Patients With Type 1 Cardiorenal Syndrome Treated With Two Strategies of Furosemide. A Randomized Controled Trial', 'orgStudyIdInfo': {'id': '112/17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GROUP A', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution\n* Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution\n* Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution\n* Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution', 'interventionNames': ['Drug: Furosemide intravenous solution']}, {'type': 'EXPERIMENTAL', 'label': 'GROUP B', 'description': 'Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:\n\n* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.\n* Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.', 'interventionNames': ['Drug: Furosemide intravenous solution', 'Drug: Chlortalidone', 'Drug: Spironolactone']}], 'interventions': [{'name': 'Furosemide intravenous solution', 'type': 'DRUG', 'description': 'Administrated as an 80 mg intravenous bolus every 24 hours in both arms and then as a continuous infusion dosed according to the experimental arm.', 'armGroupLabels': ['GROUP A', 'GROUP B']}, {'name': 'Chlortalidone', 'type': 'DRUG', 'description': 'One 50 mg pill administrated every 24 hours in group B', 'armGroupLabels': ['GROUP B']}, {'name': 'Spironolactone', 'type': 'DRUG', 'description': 'One 50 mg pill administrated every 24 hours in group B', 'armGroupLabels': ['GROUP B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44240', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'HCG', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '44240', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Hospital Civil de Guadalajara', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Civil de Guadalajara', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Jonathan Samuel Chavez Iñiguez', 'investigatorAffiliation': 'Hospital Civil de Guadalajara'}}}}