Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-26 @ 12:46 AM
Study NCT ID:
NCT03476460
Status:
COMPLETED
Last Update Posted:
2025-03-20
First Post:
2018-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Sodium Chloride and Contrast Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'martin.fabregate@salud.madrid.org', 'phone': '0034913369082', 'title': 'Coordinator of Research Support Unit, Internal Medicine Dept.', 'organization': 'Hospital Universitario Ramón y Cajal, IRYCIS'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The incidence of CA-AKI was much lower than expected at the time of study design. The definition of CA-AKI considered in our study is slightly different from that proposed in the clinical guidelines for AKI. Serial measurements of serum and urinary osmolality were not available in our trial. The trial was a single-center study, which might limit its external validity.'}}, 'adverseEventsModule': {'timeFrame': 'Within 48 hours from contrast administration (baseline).', 'description': 'Adverse events were registered, including severity and relationship with study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Oral Sodium Chloride', 'description': 'Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, patients will take 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.\n\nOral sodium chloride: Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, with 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.', 'otherNumAtRisk': 134, 'deathsNumAtRisk': 134, 'otherNumAffected': 31, 'seriousNumAtRisk': 134, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intravenous Sodium Chloride', 'description': 'Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.\n\nIntravenous sodium chloride: Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.', 'otherNumAtRisk': 137, 'deathsNumAtRisk': 137, 'otherNumAffected': 6, 'seriousNumAtRisk': 137, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Malaise/asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Leg cramps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergic reaction to contrast', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Acute Kidney Injury During the First 48 Hours After Contrast Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Sodium Chloride', 'description': 'Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, patients will take 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.\n\nOral sodium chloride: Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, with 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.'}, {'id': 'OG001', 'title': 'Intravenous Sodium Chloride', 'description': 'Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.\n\nIntravenous sodium chloride: Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '-4.8', 'ciUpperLimit': '7.0', 'estimateComment': "The 95% confidence interval for the difference between the two independent proportions was calculated according to Wilson's method.", 'groupDescription': 'Sample size was calculated to assess the non-inferiority of oral compared to intravenous hydration. We expected a primary outcome rate of 7% in the intravenous arm. We considered a priori a difference of no more than 5% in the incidence of CA-AKI in the oral compared to the intravenous arm (non-inferiority margin) to be acceptable. Thus, 266 participants, 133 per arm, were required to ensure at least 80% power at a significance level of α = 2.5% (one-sided).', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'We considered a priori a difference of no more than 5% in the incidence of CA-AKI in the oral compared to the intravenous arm (non-inferiority margin) to be acceptable.\n\nThe non-inferiority of oral hydration would be shown if the upper limit of the 95% CI of the absolute risk difference between the groups was less than 5% (non-inferiority margin, indicated by the black dashed line)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 48h after contrast administration', 'description': 'Contrast-Associated Acute Kidney Injury, defined as the increase of serum creatinine \\>0.3 mg/dL from baseline, or the reduction of estimated glomerular filtration rate (MDRD-4) \\>25%, within 48h after contrast administration', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population'}, {'type': 'SECONDARY', 'title': 'Estimated Glomerular Filtration Rate (eGFR) at 24h From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Sodium Chloride', 'description': 'Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, patients will take 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.\n\nOral sodium chloride: Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, with 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.'}, {'id': 'OG001', 'title': 'Intravenous Sodium Chloride', 'description': 'Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.\n\nIntravenous sodium chloride: Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.4', 'spread': '18.9', 'groupId': 'OG000'}, {'value': '68.8', 'spread': '18.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.299', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A p-value \\<0.05 (two-sided) was considered for statistical significance.', 'groupDescription': 'Comparison between means of both arms at 24h from baseline', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '24 hours from contrast administration (baseline)', 'description': 'Estimated glomerular filtration rate (eGFR) according to MDRD-4 at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.', 'unitOfMeasure': 'mL/min/1.73 m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Estimated Glomerular Filtration Rate (eGFR) at 48h From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Sodium Chloride', 'description': 'Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, patients will take 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.\n\nOral sodium chloride: Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, with 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.'}, {'id': 'OG001', 'title': 'Intravenous Sodium Chloride', 'description': 'Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.\n\nIntravenous sodium chloride: Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.1', 'spread': '19.7', 'groupId': 'OG000'}, {'value': '67.9', 'spread': '19.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.477', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A p-value \\<0.05 (two-sided) was considered for statistical significance.', 'groupDescription': 'Comparison between means of both arms at 48h from baseline', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '48 hours from contrast administration (baseline)', 'description': 'Estimated glomerular filtration rate (eGFR) according to MDRD-4 at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.', 'unitOfMeasure': 'mL/min/1.73 m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serum Creatinine at 24h From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Sodium Chloride', 'description': 'Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, patients will take 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.\n\nOral sodium chloride: Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, with 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.'}, {'id': 'OG001', 'title': 'Intravenous Sodium Chloride', 'description': 'Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.\n\nIntravenous sodium chloride: Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.10', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '1.02', 'spread': '0.29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.042', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A p-value \\<0.05 (two-sided) was considered for statistical significance.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison between means of both arms at 24h from baseline'}], 'paramType': 'MEAN', 'timeFrame': '24 hours from contrast administration (baseline)', 'description': 'Serum creatinine at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serum Creatinine at 48h From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Sodium Chloride', 'description': 'Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, patients will take 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.\n\nOral sodium chloride: Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, with 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.'}, {'id': 'OG001', 'title': 'Intravenous Sodium Chloride', 'description': 'Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.\n\nIntravenous sodium chloride: Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.10', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '1.04', 'spread': '0.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.121', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A p-value \\<0.05 (two-sided) was considered for statistical significance', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison between means of both arms at 48h from baseline'}], 'paramType': 'MEAN', 'timeFrame': '48 hours from contrast administration (baseline)', 'description': 'Serum creatinine at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cystatin C at 24h From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Sodium Chloride', 'description': 'Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, patients will take 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.\n\nOral sodium chloride: Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, with 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.'}, {'id': 'OG001', 'title': 'Intravenous Sodium Chloride', 'description': 'Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.\n\nIntravenous sodium chloride: Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.38', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '1.33', 'spread': '0.46', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.418', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A p-value \\<0.05 (two-sided) was considered for statistical significance.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison between means of both arms at 24h from baseline'}], 'paramType': 'MEAN', 'timeFrame': '24 hours from contrast administration (baseline)', 'description': 'Cystatin C at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cystatin C at 48h From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Sodium Chloride', 'description': 'Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, patients will take 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.\n\nOral sodium chloride: Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, with 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.'}, {'id': 'OG001', 'title': 'Intravenous Sodium Chloride', 'description': 'Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.\n\nIntravenous sodium chloride: Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.36', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '1.36', 'spread': '0.46', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.901', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A p-value \\<0.05 (two-sided) was considered for statistical significance', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison between means of both arms at 24h from baseline'}], 'paramType': 'MEAN', 'timeFrame': '48 hours from contrast administration (baseline)', 'description': 'Cystatin C at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Albumin-to-creatinine Ratio at 24h From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Sodium Chloride', 'description': 'Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, patients will take 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.\n\nOral sodium chloride: Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, with 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.'}, {'id': 'OG001', 'title': 'Intravenous Sodium Chloride', 'description': 'Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.\n\nIntravenous sodium chloride: Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.2', 'groupId': 'OG000', 'lowerLimit': '8.3', 'upperLimit': '72.0'}, {'value': '17.0', 'groupId': 'OG001', 'lowerLimit': '9.3', 'upperLimit': '65.5'}]}]}], 'analyses': [{'pValue': '0.720', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A p-value \\<0.05 (two-sided) was considered for statistical significance', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison between means of both arms at 24h from baseline'}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours from contrast administration (baseline)', 'description': 'Albumin-to-creatinine ratio at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.', 'unitOfMeasure': 'mg/g', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Albumin-to-creatinine Ratio at 48h From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Sodium Chloride', 'description': 'Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, patients will take 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.\n\nOral sodium chloride: Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, with 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.'}, {'id': 'OG001', 'title': 'Intravenous Sodium Chloride', 'description': 'Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.\n\nIntravenous sodium chloride: Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000', 'lowerLimit': '9.0', 'upperLimit': '69.2'}, {'value': '18.2', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': '50.1'}]}]}], 'analyses': [{'pValue': '0.688', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A p-value \\<0.05 (two-sided) was considered for statistical significance', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison between means of both arms at 48h from baseline'}], 'paramType': 'MEDIAN', 'timeFrame': '48 hours from contrast administration (baseline)', 'description': 'Albumin-to-creatinine ratio at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.', 'unitOfMeasure': 'mg/g', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Urea at 24h From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Sodium Chloride', 'description': 'Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, patients will take 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.\n\nOral sodium chloride: Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, with 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.'}, {'id': 'OG001', 'title': 'Intravenous Sodium Chloride', 'description': 'Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.\n\nIntravenous sodium chloride: Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.7', 'spread': '18.7', 'groupId': 'OG000'}, {'value': '42.2', 'spread': '18.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.535', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A p-value \\<0.05 (two-sided) was considered for statistical significance', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison between means of both arms at 24h from baseline'}], 'paramType': 'MEAN', 'timeFrame': '24 hours from contrast administration (baseline)', 'description': 'Urea at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Urea at 48h From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Sodium Chloride', 'description': 'Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, patients will take 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.\n\nOral sodium chloride: Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, with 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.'}, {'id': 'OG001', 'title': 'Intravenous Sodium Chloride', 'description': 'Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.\n\nIntravenous sodium chloride: Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.0', 'spread': '19.5', 'groupId': 'OG000'}, {'value': '43.5', 'spread': '20.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.338', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A p-value \\<0.05 (two-sided) was considered for statistical significance', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison between means of both arms at 48h from baseline'}], 'paramType': 'MEAN', 'timeFrame': '48 hours from contrast administration (baseline)', 'description': 'Urea at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serum Sodium at 24h From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Sodium Chloride', 'description': 'Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, patients will take 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.\n\nOral sodium chloride: Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, with 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.'}, {'id': 'OG001', 'title': 'Intravenous Sodium Chloride', 'description': 'Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.\n\nIntravenous sodium chloride: Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '139.4', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '139.3', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.764', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A p-value \\<0.05 (two-sided) was considered for statistical significance', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison between means of both arms at 24h from baseline'}], 'paramType': 'MEAN', 'timeFrame': '24 hours from contrast administration (baseline)', 'description': 'Serum sodium at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serum Sodium at 48h From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Sodium Chloride', 'description': 'Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, patients will take 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.\n\nOral sodium chloride: Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, with 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.'}, {'id': 'OG001', 'title': 'Intravenous Sodium Chloride', 'description': 'Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.\n\nIntravenous sodium chloride: Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '139.2', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '139.4', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.458', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A p-value \\<0.05 (two-sided) was considered for statistical significance.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison between means of both arms at 48h from baseline'}], 'paramType': 'MEAN', 'timeFrame': '48 hours from contrast administration (baseline)', 'description': 'Serum sodium at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serum Potassium at 24h From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Sodium Chloride', 'description': 'Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, patients will take 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.\n\nOral sodium chloride: Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, with 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.'}, {'id': 'OG001', 'title': 'Intravenous Sodium Chloride', 'description': 'Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.\n\nIntravenous sodium chloride: Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.893', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A p-value \\<0.05 (two-sided) was considered for statistical significance.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison between means of both arms at 24h from baseline'}], 'paramType': 'MEAN', 'timeFrame': '24 hours from contrast administration (baseline)', 'description': 'Serum potassium at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serum Potassium at 48h From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Sodium Chloride', 'description': 'Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, patients will take 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.\n\nOral sodium chloride: Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, with 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.'}, {'id': 'OG001', 'title': 'Intravenous Sodium Chloride', 'description': 'Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.\n\nIntravenous sodium chloride: Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.645', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A p-value \\<0.05 (two-sided) was considered for statistical significance.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison between means of both arms at 48h from baseline'}], 'paramType': 'MEAN', 'timeFrame': '48 hours from contrast administration (baseline)', 'description': 'Serum potassium at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oral Sodium Chloride', 'description': 'Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, patients will take 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.\n\nOral sodium chloride: Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, with 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.'}, {'id': 'FG001', 'title': 'Intravenous Sodium Chloride', 'description': 'Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.\n\nIntravenous sodium chloride: Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '134'}, {'groupId': 'FG001', 'numSubjects': '137'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}, {'groupId': 'FG001', 'numSubjects': '129'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Non-compliance with treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Missing laboratory tests', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited at Hospital Universitario Ramón y Cajal, Madrid, Spain, between April 2014 and November 2019.', 'preAssignmentDetails': 'A total of 271 patients were enrolled in the study, of whom 19 (7.0%) did not meet the criteria for per-protocol analysis and were therefore excluded from the main analysis. The reasons for exclusion included voluntary withdrawal (n=5), hospitalisation for bronchospasm (n=1), missing laboratory tests (n=10), and non-compliance with treatment (n=3). Thus, the main analysis (per-protocol) consisted of n=252 patients, of whom 123 received oral hydration and 129 received intravenous hydration.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Oral Sodium Chloride', 'description': 'Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, patients will take 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.\n\nOral sodium chloride: Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, with 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.'}, {'id': 'BG001', 'title': 'Intravenous Sodium Chloride', 'description': 'Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.\n\nIntravenous sodium chloride: Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '74.1', 'spread': '6.1', 'groupId': 'BG000'}, {'value': '74.6', 'spread': '6.8', 'groupId': 'BG001'}, {'value': '74.4', 'spread': '6.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Spain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hypertension', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '184', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Current smoker', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cancer', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Chronic kidney disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Heart failure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Peripheral artery disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Estimated glomerular filtration rate (eGFR) according to MDRD-4', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '66.6', 'spread': '19.4', 'groupId': 'BG000'}, {'value': '69.0', 'spread': '19.6', 'groupId': 'BG001'}, {'value': '67.8', 'spread': '19.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mL/min/1.73m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Serum creatinine', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.09', 'spread': '0.31', 'groupId': 'BG000'}, {'value': '1.02', 'spread': '0.29', 'groupId': 'BG001'}, {'value': '1.06', 'spread': '0.30', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Cystatin C', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.36', 'spread': '0.39', 'groupId': 'BG000'}, {'value': '1.41', 'spread': '0.46', 'groupId': 'BG001'}, {'value': '1.38', 'spread': '0.43', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Albumin-to-creatinine ratio', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '17.4', 'groupId': 'BG000', 'lowerLimit': '10.1', 'upperLimit': '81.9'}, {'value': '19.4', 'groupId': 'BG001', 'lowerLimit': '8.3', 'upperLimit': '61.0'}, {'value': '19.0', 'groupId': 'BG002', 'lowerLimit': '8.8', 'upperLimit': '66.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/g', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Urea', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '49.1', 'spread': '16.2', 'groupId': 'BG000'}, {'value': '46.7', 'spread': '18.8', 'groupId': 'BG001'}, {'value': '47.8', 'spread': '17.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Serum sodium', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '139.2', 'spread': '2.6', 'groupId': 'BG000'}, {'value': '139.6', 'spread': '3.1', 'groupId': 'BG001'}, {'value': '139.4', 'spread': '2.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Serum potassium', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '0.4', 'groupId': 'BG000'}, {'value': '4.5', 'spread': '0.5', 'groupId': 'BG001'}, {'value': '4.5', 'spread': '0.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'B-type natriuretic peptide (BNP)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '56.6', 'groupId': 'BG000', 'lowerLimit': '24.4', 'upperLimit': '153.5'}, {'value': '54.0', 'groupId': 'BG001', 'lowerLimit': '29.6', 'upperLimit': '100.3'}, {'value': '55.9', 'groupId': 'BG002', 'lowerLimit': '27.9', 'upperLimit': '119.9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pg/mg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Hemoglobin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13.6', 'spread': '1.8', 'groupId': 'BG000'}, {'value': '13.7', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '13.6', 'spread': '1.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Non-diuretic antihypertensives', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Non-insulin antidiabetic drugs', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Lipid-lowering agents', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diuretics', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body mass index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '23.0', 'spread': '3.9', 'groupId': 'BG000'}, {'value': '23.0', 'spread': '3.7', 'groupId': 'BG001'}, {'value': '23.0', 'spread': '3.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Systolic blood pressure (SBP)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '140.2', 'spread': '19.8', 'groupId': 'BG000'}, {'value': '143.1', 'spread': '20.2', 'groupId': 'BG001'}, {'value': '141.7', 'spread': '20.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Heart rate', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '71.1', 'spread': '13.9', 'groupId': 'BG000'}, {'value': '70.9', 'spread': '11.1', 'groupId': 'BG001'}, {'value': '71.0', 'spread': '12.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'bpm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Peripheral oxygen saturation (spO2)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '95.8', 'spread': '2.4', 'groupId': 'BG000'}, {'value': '95.4', 'spread': '3.0', 'groupId': 'BG001'}, {'value': '95.6', 'spread': '2.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of hemoglobin saturation', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-08-02', 'size': 976419, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-04T09:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 271}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2019-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-14', 'studyFirstSubmitDate': '2018-03-17', 'resultsFirstSubmitDate': '2023-08-04', 'studyFirstSubmitQcDate': '2018-03-22', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-14', 'studyFirstPostDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Acute Kidney Injury During the First 48 Hours After Contrast Administration', 'timeFrame': 'Within 48h after contrast administration', 'description': 'Contrast-Associated Acute Kidney Injury, defined as the increase of serum creatinine \\>0.3 mg/dL from baseline, or the reduction of estimated glomerular filtration rate (MDRD-4) \\>25%, within 48h after contrast administration'}], 'secondaryOutcomes': [{'measure': 'Estimated Glomerular Filtration Rate (eGFR) at 24h From Baseline', 'timeFrame': '24 hours from contrast administration (baseline)', 'description': 'Estimated glomerular filtration rate (eGFR) according to MDRD-4 at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.'}, {'measure': 'Estimated Glomerular Filtration Rate (eGFR) at 48h From Baseline', 'timeFrame': '48 hours from contrast administration (baseline)', 'description': 'Estimated glomerular filtration rate (eGFR) according to MDRD-4 at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.'}, {'measure': 'Serum Creatinine at 24h From Baseline', 'timeFrame': '24 hours from contrast administration (baseline)', 'description': 'Serum creatinine at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.'}, {'measure': 'Serum Creatinine at 48h From Baseline', 'timeFrame': '48 hours from contrast administration (baseline)', 'description': 'Serum creatinine at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.'}, {'measure': 'Cystatin C at 24h From Baseline', 'timeFrame': '24 hours from contrast administration (baseline)', 'description': 'Cystatin C at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.'}, {'measure': 'Cystatin C at 48h From Baseline', 'timeFrame': '48 hours from contrast administration (baseline)', 'description': 'Cystatin C at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.'}, {'measure': 'Albumin-to-creatinine Ratio at 24h From Baseline', 'timeFrame': '24 hours from contrast administration (baseline)', 'description': 'Albumin-to-creatinine ratio at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.'}, {'measure': 'Albumin-to-creatinine Ratio at 48h From Baseline', 'timeFrame': '48 hours from contrast administration (baseline)', 'description': 'Albumin-to-creatinine ratio at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.'}, {'measure': 'Urea at 24h From Baseline', 'timeFrame': '24 hours from contrast administration (baseline)', 'description': 'Urea at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.'}, {'measure': 'Urea at 48h From Baseline', 'timeFrame': '48 hours from contrast administration (baseline)', 'description': 'Urea at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.'}, {'measure': 'Serum Sodium at 24h From Baseline', 'timeFrame': '24 hours from contrast administration (baseline)', 'description': 'Serum sodium at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.'}, {'measure': 'Serum Sodium at 48h From Baseline', 'timeFrame': '48 hours from contrast administration (baseline)', 'description': 'Serum sodium at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.'}, {'measure': 'Serum Potassium at 24h From Baseline', 'timeFrame': '24 hours from contrast administration (baseline)', 'description': 'Serum potassium at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.'}, {'measure': 'Serum Potassium at 48h From Baseline', 'timeFrame': '48 hours from contrast administration (baseline)', 'description': 'Serum potassium at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute kidney failure', 'CT scan', 'Iodine contrast', 'Sodium chloride'], 'conditions': ['Kidney Failure, Chronic', 'Kidney Failure, Acute', 'Heart Failure', 'Diabetes']}, 'referencesModule': {'references': [{'pmid': '37109303', 'type': 'RESULT', 'citation': 'Suarez Carantona C, Escobar Cervantes C, Fabregate M, Lopez Rodriguez M, Bara Ledesma N, Soto Perez-Olivares J, Ruiz Ortega RA, Lopez Castellanos G, Olavarria Delgado A, Blazquez Sanchez J, Gomez Del Olmo V, Moralejo Martin M, Pumares Alvarez MB, Sanchez Gallego MC, Llacer P, Liano F, Manzano L. Oral Sodium Chloride in the Prevention of Contrast-Associated Acute Kidney Injury in Elderly Outpatients: The PNIC-Na Randomized Non-Inferiority Trial. J Clin Med. 2023 Apr 19;12(8):2965. doi: 10.3390/jcm12082965.'}]}, 'descriptionModule': {'briefSummary': 'This phase II, open, non-inferiority, randomized and controlled clinical trial is aimed to ascertain the incidence of contrast nephropathy in outpatients undergoing CT scan with contrast.\n\nPatients will be randomized to receive oral prophylaxis with capsules of sodium chloride and free water ingestion or prophylaxis with sodium chloride 0.9% intravenous solution.\n\nThe total dose (mmol) of sodium chloride will be the same regardless administration via. The contrast will be iodixanol.\n\nPatients \\>65 years, of both sexes, with at least one of the following criteria: diabetes, stable heart failure or chronic kidney disease (estimated glomerular filtration rate between 30 and 60 ml/min), undergoing CT scan with contrast, and who give written informed consent, will be included in the study. Patients with estimated glomerular filtration rate \\<30 ml/min, serum potassium \\<3.5 mEq/L, infusion of iodine contrast in the previous 15 days, administration of nephrotoxic drugs in the previous 72 hours or expected in the following hours after contrast infusion, decompensated chronic conditions (heart failure, chronic obstructive pulmonary disease, hypertension), allergy to iodine contrast, or the presence of hyperchloremia or hypernatremia, will be excluded from the study.\n\nContrast nephropathy will be defined as the increase of serum creatinine \\>0.3 mg/dL from baseline, or the reduction of estimated glomerular filtration rate (MDRD-4) \\>25% from baseline, in the first 48 hours after contrast administration.', 'detailedDescription': 'This phase II, open, non-inferiority, randomized and controlled clinical trial is aimed to ascertain the incidence of contrast nephropathy in outpatients undergoing CT scan with contrast.\n\nPatients will be randomized to receive oral prophylaxis with capsules of sodium chloride and free water ingestion or prophylaxis with sodium chloride 0.9% intravenous solution.\n\nIn those patients randomly allocated to oral prophylaxis (n=133), patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, patients will take 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast. In those patients randomly allocated to receive sodium chloride 0.9% intravenous solution (n=133), patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection. The total dose (mmol) of sodium chloride will be the same regardless administration via. The contrast will be iodixanol (320 mg of iodine/ml, in 100 ml, at an infusion rate of 2-5 ml/sec).\n\nPatients \\>65 years, of both sexes, with at least one of the following criteria: diabetes, stable heart failure or chronic kidney disease (estimated glomerular filtration rate between 30 and 60 ml/min), undergoing CT scan with contrast, and who give written informed consent, will be included in the study. Patients with estimated glomerular filtration rate \\<30 ml/min, serum potassium \\<3.5 mEq/L, infusion of iodine contrast in the previous 15 days, administration of nephrotoxic drugs in the previous 72 hours or expected in the following hours after contrast infusion, decompensated chronic conditions (heart failure, chronic obstructive pulmonary disease, hypertension), allergy to iodine contrast, or the presence of hyperchloremia or hypernatremia, will be excluded from the study.\n\nContrast nephropathy will be defined as the increase of serum creatinine \\>0.3 mg/dL from baseline, or the reduction of estimated glomerular filtration rate (MDRD-4) \\>25% from baseline, in the first 48 hours after contrast administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\>65 years,\n* Both sexes,\n* With at least one of the following criteria: diabetes or stable heart failure or chronic kidney disease (estimated glomerular filtration rate between 30 and 60 ml/min),\n* Undergoing CT scan with contrast\n* Written informed consent.\n\nExclusion Criteria:\n\n* Estimated glomerular filtration rate \\<30 ml/min,\n* Serum potassium \\<3.5 mEq/L,\n* Infusion of iodine contrast in the previous 15 days,\n* Administration of nephrotoxic drugs in the previous 72 hours or expected in the following hours after contrast infusion,\n* Decompensated chronic conditions (heart failure, chronic obstructive pulmonary disease, hypertension),\n* Allergy to iodine contrast,\n* Presence of hyperchloremia or hypernatremia.'}, 'identificationModule': {'nctId': 'NCT03476460', 'acronym': 'PNIC-Na', 'briefTitle': 'Sodium Chloride and Contrast Nephropathy', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Ramon y Cajal'}, 'officialTitle': 'Efficacy of Oral Sodium Chloride vs iv Sodium Chloride in the Prevention of Contrast Nephropathy in Outpatients', 'orgStudyIdInfo': {'id': 'EC11-132'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral sodium chloride', 'description': 'Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, patients will take 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.', 'interventionNames': ['Drug: Oral sodium chloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous sodium chloride', 'description': 'Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.', 'interventionNames': ['Drug: Intravenous sodium chloride']}], 'interventions': [{'name': 'Oral sodium chloride', 'type': 'DRUG', 'description': 'Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, with 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.', 'armGroupLabels': ['Oral sodium chloride']}, {'name': 'Intravenous sodium chloride', 'type': 'DRUG', 'description': 'Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.', 'armGroupLabels': ['Intravenous sodium chloride']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Ramon y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Luis Manzano, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Ramon y Cajal'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'After revision and approval of the principal investigator.', 'ipdSharing': 'YES', 'description': 'Data Availability Statement The data presented in this study are available on request from the corresponding author. The data are not publicly available due to participant confidentiality.', 'accessCriteria': 'Approval of the principal investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Ramon y Cajal', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto de Salud Carlos III', 'class': 'OTHER_GOV'}, {'name': 'Ministerio de Sanidad, Servicios Sociales e Igualdad', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Chief of Internal Medicine department', 'investigatorFullName': 'Luis Manzano Espinosa', 'investigatorAffiliation': 'Hospital Universitario Ramon y Cajal'}}}}