Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-01-04 @ 12:10 AM
Study NCT ID:
NCT02462902
Status:
COMPLETED
Last Update Posted:
2015-12-30
First Post:
2015-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison And Outcomes Of Fluid Resucitation With 0.9% Normal Saline And 5% Albumin In Cirrhosis Patients With Sepsis Induced Hypotension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 308}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-29', 'studyFirstSubmitDate': '2015-05-25', 'studyFirstSubmitQcDate': '2015-06-01', 'lastUpdatePostDateStruct': {'date': '2015-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total number of patients with MAP (Mean Arterial Pressure) ≥ 65', 'timeFrame': '3 hours'}], 'secondaryOutcomes': [{'measure': 'Change in lactate dynamics', 'timeFrame': '3 hours'}, {'measure': 'Total number of patients with Urine output >/= 0.5mL/kg/hr.', 'timeFrame': '3 hours'}, {'measure': 'Mortality', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cirrhosis With Septic Shock']}, 'descriptionModule': {'briefSummary': '300 consecutive patients with cirrhosis of any aetiology admitted with features of sepsis and sepsis induced hypotension to the intensive care unit, the emergency department and the step down units of Institute of Liver and Biliary Sciences, New Delhi, who fulfil the inclusion criteria.\n\nThis study will be a single centre prospective randomized comparative trial. Patients will be randomized into two groups. Group A will receive crystalloid, 0.9% sodium chloride solution (total of 30ml/kg over 30 minutes) and Group B will receive colloid, 5% albumin (250 ml over 15 minutes).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Cirrhotic patients of any aetiology with Infection - suspected or documented and Mean arterial pressure less than 65 mm of Hg\n\nExclusion Criteria:\n\n1. Cirrhosis patients in septic shock who are already on vasopressors and/or inotropes\n2. Cirrhosis patients in septic shock with structural heart disease\n3. Cirrhosis patients in septic shock with chronic renal failure/dialysis dependent/volume overloaded state\n4. Cirrhosis patients in shock, caused by other reasons, other than septic shock\n5. Cirrhosis patients in septic shock in whom contraindication to internal jugular or subclavian line insertion is present\n6. Age less than 18 years\n7. Previous episode of septic shock during the same hospital stay\n8. Pregnant or lactating women\n9. Patients in need for emergent surgical interventions\n10. Cirrhosis patients in septic shock with chronic obstructive lung disease and right heart failure\n11. Cirrhosis patients in septic shock with associated upper gastrointestinal bleed or coagulopathy related bleed with a haemoglobin of less than 8g/dL or requiring urgent transfusions of blood and blood products\n12. A previous adverse reaction to human albumin solution'}, 'identificationModule': {'nctId': 'NCT02462902', 'briefTitle': 'Comparison And Outcomes Of Fluid Resucitation With 0.9% Normal Saline And 5% Albumin In Cirrhosis Patients With Sepsis Induced Hypotension', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Liver and Biliary Sciences, India'}, 'officialTitle': 'Comparison And Outcomes Of Fluid Resucitation With 0.9% Normal Saline And 5% Albumin In Cirrhosis Patients With Sepsis Induced Hypotension', 'orgStudyIdInfo': {'id': 'ILBS-Cirrhosis with sepsis-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '5% albumin Infusion', 'description': '(250 ml over 15 to 30 minutes)', 'interventionNames': ['Drug: 5% albumin Infusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': '0.9% sodium chloride solution', 'description': '0.9% sodium chloride solution (total of 30ml/kg over 15 to 30 minute)', 'interventionNames': ['Drug: 0.9% sodium chloride solution']}], 'interventions': [{'name': '5% albumin Infusion', 'type': 'DRUG', 'description': 'colloid, 5% albumin (250 ml over 15 to 30 minutes).', 'armGroupLabels': ['5% albumin Infusion']}, {'name': '0.9% sodium chloride solution', 'type': 'DRUG', 'description': '0.9% sodium chloride solution (total of 30ml/kg over 15 to 30 minutes)', 'armGroupLabels': ['0.9% sodium chloride solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110070', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'Institute of Liver and Biliary Sciences', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Liver and Biliary Sciences, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}