Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-02-23 @ 1:12 AM
Study NCT ID:
NCT02351934
Status:
COMPLETED
Last Update Posted:
2018-05-07
First Post:
2015-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Early Diuresis Following Colorectal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005665', 'term': 'Furosemide'}, {'id': 'D000068579', 'term': 'Celecoxib'}, {'id': 'D000077206', 'term': 'Gabapentin'}], 'ancestors': [{'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Danelich.Ilya@mayo.edu', 'phone': '507-255-5732', 'title': 'Ilya Danelich, Pharm.D., R.Ph.', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 month', 'eventGroups': [{'id': 'EG000', 'title': 'Furosemide + Enhanced Recovery After Surgery (ERAS)', 'description': 'Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 8, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Enhanced Recovery After Surgery (ERAS)', 'description': 'ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 3, 'seriousNumAtRisk': 61, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Decreased Potassium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased Serum Creatinine', 'notes': "If your kidneys aren't functioning properly, an increased level of creatinine may accumulate in your blood.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased blood pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urine leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased heart rate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased temperature', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma/Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Furosemide + Enhanced Recovery After Surgery (ERAS)', 'description': 'Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.'}, {'id': 'OG001', 'title': 'Enhanced Recovery After Surgery (ERAS)', 'description': 'ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000', 'lowerLimit': '73.1', 'upperLimit': '150.6'}, {'value': '80.6', 'groupId': 'OG001', 'lowerLimit': '73.6', 'upperLimit': '124.0'}]}]}], 'analyses': [{'pValue': '0.564', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Significance level of 0.05 was used.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 7 days', 'description': 'Participants will be followed for the duration of hospital stay, an expected average of 2-7 days.', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis'}, {'type': 'SECONDARY', 'title': 'Number of Participants Readmitted to Mayo Clinic Within 30-days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Furosemide + Enhanced Recovery After Surgery (ERAS)', 'description': 'Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.'}, {'id': 'OG001', 'title': 'Enhanced Recovery After Surgery (ERAS)', 'description': 'ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.675', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Significance level of 0.05 was used.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 30 days of release from hospital', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat analysis'}, {'type': 'SECONDARY', 'title': 'Number of Participants Requiring Nasogastric Tube Placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Furosemide + Enhanced Recovery After Surgery (ERAS)', 'description': 'Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.'}, {'id': 'OG001', 'title': 'Enhanced Recovery After Surgery (ERAS)', 'description': 'ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.125', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Significance level of 0.05 was used.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 7 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat Analysis'}, {'type': 'SECONDARY', 'title': 'Time to Stool Output', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Furosemide + Enhanced Recovery After Surgery (ERAS)', 'description': 'Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.'}, {'id': 'OG001', 'title': 'Enhanced Recovery After Surgery (ERAS)', 'description': 'ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.8', 'groupId': 'OG000', 'lowerLimit': '27.8', 'upperLimit': '82.2'}, {'value': '45.4', 'groupId': 'OG001', 'lowerLimit': '22.7', 'upperLimit': '68.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 4 days', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat analysis'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Acute Kidney Injury', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Furosemide + Enhanced Recovery After Surgery (ERAS)', 'description': 'Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.'}, {'id': 'OG001', 'title': 'Enhanced Recovery After Surgery (ERAS)', 'description': 'ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.595', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Significance level of 0.05 was used.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 7 days', 'description': 'Acute kidney injury (AKI) refers to an abrupt decrease in kidney function, resulting in the retention of urea and other nitrogenous waste products and in the dysregulation of extracellular volume and electrolytes. The term AKI has largely replaced acute renal failure (ARF), reflecting the recognition that smaller decrements in kidney function that do not result in overt organ failure are of substantial clinical relevance and are associated with increased morbidity and mortality. The AKI experienced by these patients was not considered an adverse event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat analysis'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Hypokalemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Furosemide + Enhanced Recovery After Surgery (ERAS)', 'description': 'Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.'}, {'id': 'OG001', 'title': 'Enhanced Recovery After Surgery (ERAS)', 'description': 'ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.985', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Significance level of 0.05 was used.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 7 days', 'description': 'Hypokalemia is generally defined as a serum potassium level of less than 3.5 mmol/L.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Furosemide + Enhanced Recovery After Surgery (ERAS)', 'description': 'Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.'}, {'id': 'FG001', 'title': 'Enhanced Recovery After Surgery (ERAS)', 'description': 'ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.'}], 'periods': [{'title': 'Allocation', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'Received Allocation', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'POD weight<pre-op weight', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Hypotension preventing administration', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Acute Kidney Injury on Post Op Day 1', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Follow-Up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'POD weight<pre-op weight', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Acute Kidney Injury', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Early dismissal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Hypotension', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'No documentation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': '1 ERAS Component Noncompliant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': '2 ERAS Components Noncompliant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Subjects were enrolled at Mayo Clinic in Rochester, Minnesota between February 2015 and April 2016.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Furosemide + Enhanced Recovery After Surgery (ERAS)', 'description': 'Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.'}, {'id': 'BG001', 'title': 'Enhanced Recovery After Surgery (ERAS)', 'description': 'ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000', 'lowerLimit': '42', 'upperLimit': '68'}, {'value': '61', 'groupId': 'BG001', 'lowerLimit': '45', 'upperLimit': '68'}, {'value': '59', 'groupId': 'BG002', 'lowerLimit': '42', 'upperLimit': '68'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intention to treat analysis'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-04', 'studyFirstSubmitDate': '2015-01-23', 'resultsFirstSubmitDate': '2017-06-02', 'studyFirstSubmitQcDate': '2015-01-27', 'lastUpdatePostDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-02', 'studyFirstPostDateStruct': {'date': '2015-01-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of Hospital Stay', 'timeFrame': 'Up to 7 days', 'description': 'Participants will be followed for the duration of hospital stay, an expected average of 2-7 days.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Readmitted to Mayo Clinic Within 30-days', 'timeFrame': 'Within 30 days of release from hospital'}, {'measure': 'Number of Participants Requiring Nasogastric Tube Placement', 'timeFrame': 'Up to 7 days'}, {'measure': 'Time to Stool Output', 'timeFrame': 'Up to 4 days'}, {'measure': 'Number of Participants With Acute Kidney Injury', 'timeFrame': 'Up to 7 days', 'description': 'Acute kidney injury (AKI) refers to an abrupt decrease in kidney function, resulting in the retention of urea and other nitrogenous waste products and in the dysregulation of extracellular volume and electrolytes. The term AKI has largely replaced acute renal failure (ARF), reflecting the recognition that smaller decrements in kidney function that do not result in overt organ failure are of substantial clinical relevance and are associated with increased morbidity and mortality. The AKI experienced by these patients was not considered an adverse event.'}, {'measure': 'Number of Participants With Hypokalemia', 'timeFrame': 'Up to 7 days', 'description': 'Hypokalemia is generally defined as a serum potassium level of less than 3.5 mmol/L.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colorectal surgery', 'volume status'], 'conditions': ['Colorectal Disorders']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to find out if giving a medicine called furosemide, which is a diuretic or water pill, after colon surgery will safely shorten the patient's length of hospital stay.", 'detailedDescription': 'This study will assess if administration of a loop diuretic, specifically furosemide, to achieve euvolemia can safely reduce length of stay following colorectal surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n* All elective colorectal surgeries (CRS) utilizing the enhanced recovery pathway (ERP)\n* The surgery involves resection\n\nExclusion Criteria\n\nExclusion Criteria for Randomization:\n\n* Surgeries involving intraoperative radiation\n* Ileostomy closures, when performed as the only surgical intervention\n* Surgeries involving multiple disciplines (e.g., colorectal plus general surgery, colorectal plus gynecology surgery) except for colorectal surgeries plus ureteral stent placements.\n* Chronic loop diuretic therapy (i.e., bumetanide, torsemide, furosemide, ethacrynic acid) including as needed administration of such therapy\n* Patients receiving dialysis\n* Creatinine clearance, calculated by the Cockcroft-Gault equation, less than 30 mL/min.\n* Inpatient prior to surgery\n* Allergy to furosemide\n* Allergy to sulfa drugs if the allergy involves anaphylactic reaction\n* Lack of serum creatinine concentration within 3 months preceding the surgery AND diagnosis of chronic kidney disease\n\nExclusion Criteria for Intervention (applies to both the intervention and control arm):\n\n* Patient's weight on postoperative day (POD) #1 and POD #2 is less than preoperative weight.\n* Blood pressure criteria: systolic blood pressure criteria less than 90 mmHg or greater than 30 mmHg below baseline on POD #1 and/or POD #2 immediately prior to administration of study drug.\n* Complications within 48 hours of surgery\n* Abscess (infected fluid collection, treated with CT drainage)\n* Leak (defined by CT drainage or reoperation)\n* Wound infection (treated with either antibiotics and/or open packing)\n* Bowel obstruction (treated with reoperation)\n* Reoperation\n* Hemorrhage\n* Weight change since admission on POD #1: \\> 5 kg\n* Acute kidney injury on POD #1 and POD#2 defined as serum creatinine (SCr) increase ≥ 0.3 mg/dL or increase to ≥ 150% to 200% (1.5- to 2-fold) from baseline"}, 'identificationModule': {'nctId': 'NCT02351934', 'briefTitle': 'Early Diuresis Following Colorectal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Prospective, Randomized Study Evaluating the Efficacy and Safety of Early Diuresis Following Colorectal Surgery', 'orgStudyIdInfo': {'id': '14-008292'}, 'secondaryIdInfos': [{'id': 'UL1TR000135', 'link': 'https://reporter.nih.gov/quickSearch/UL1TR000135', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Furosemide + Enhanced Recovery after Surgery (ERAS)', 'description': 'Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.', 'interventionNames': ['Drug: Furosemide', 'Drug: Celecoxib', 'Drug: Gabapentin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced Recovery after Surgery (ERAS)', 'description': 'ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.', 'interventionNames': ['Drug: Celecoxib', 'Drug: Gabapentin']}], 'interventions': [{'name': 'Furosemide', 'type': 'DRUG', 'otherNames': ['Lasix'], 'armGroupLabels': ['Furosemide + Enhanced Recovery after Surgery (ERAS)']}, {'name': 'Celecoxib', 'type': 'DRUG', 'otherNames': ['Celebrex'], 'description': 'Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain or inflammation.', 'armGroupLabels': ['Enhanced Recovery after Surgery (ERAS)', 'Furosemide + Enhanced Recovery after Surgery (ERAS)']}, {'name': 'Gabapentin', 'type': 'DRUG', 'otherNames': ['Neurontin'], 'description': 'Gabapentin is a oral drug used to treat seizures, postherpetic neuralgia, and restless legs syndrome.', 'armGroupLabels': ['Enhanced Recovery after Surgery (ERAS)', 'Furosemide + Enhanced Recovery after Surgery (ERAS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Ilya Danelich, PharmD, RPh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Ilya M. Danelich, Pharm.D., R.Ph.', 'investigatorAffiliation': 'Mayo Clinic'}}}}