Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-04-08 @ 11:50 PM
Study NCT ID:
NCT02937935
Status:
UNKNOWN
Last Update Posted:
2017-11-29
First Post:
2016-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
On Demand Versus Protocol-guided Renal Replacement Therapy for Management of Stage 3 Acute Kidney Injury in Patients With Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2019-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-28', 'studyFirstSubmitDate': '2016-10-17', 'studyFirstSubmitQcDate': '2016-10-17', 'lastUpdatePostDateStruct': {'date': '2017-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recovery of renal functions in both groups', 'timeFrame': 'day 14'}], 'secondaryOutcomes': [{'measure': 'Adverse effects of dialysis in the first session in both groups', 'timeFrame': '48 hours'}, {'measure': 'Improvement in SOFA (by 2 points) scores in both groups', 'timeFrame': '48 hours'}, {'measure': 'Improvement in MELD ( by 2 points) scores in both groups', 'timeFrame': '48 hours'}, {'measure': 'Improvement in APACHE ( by 2 points) scores in both groups', 'timeFrame': '48 hours'}, {'measure': 'Change to End Stage Renal Disease with requirement of maintenance hemodialysis at least twice a week in both groups', 'timeFrame': '4 weeks'}, {'measure': 'Improvement in renal functions in both groups', 'timeFrame': '7 days'}, {'measure': 'Mortality in both groups', 'timeFrame': '1 month'}, {'measure': 'Mortality in both groups', 'timeFrame': '3 month'}, {'measure': 'Response to vasoconstrictors in patients with Hepatorenal Syndrome-Acute Kidney Injury in both groups.', 'timeFrame': '6 hours', 'description': 'Response as assessed by either improvement in urine output \\>0.5ml/kg/hour, acid-base status or renal functions.'}, {'measure': 'Response to vasoconstrictors in patients with Hepatorenal Syndrome-Acute Kidney Injury in both groups.', 'timeFrame': '12 hours', 'description': 'Response as assessed by either improvement in urine output \\>0.5ml/kg/hour, acid-base status or renal functions.'}, {'measure': 'Response to vasoconstrictors in patients with Hepatorenal Syndrome-Acute Kidney Injury', 'timeFrame': '24 hours', 'description': 'Response as assessed by either improvement in urine output \\>0.5ml/kg/hour, acid-base status or renal functions.'}, {'measure': 'Response to vasoconstrictors in patients with Hepatorenal Syndrome-Acute Kidney Injury in both groups', 'timeFrame': '24 hours', 'description': 'Response as assessed by either improvement in urine output \\>0.5ml/kg/hour, acid-base status or renal functions.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Kidney Injury With Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '36416787', 'type': 'DERIVED', 'citation': 'Fayad AI, Buamscha DG, Ciapponi A. Timing of kidney replacement therapy initiation for acute kidney injury. Cochrane Database Syst Rev. 2022 Nov 23;11(11):CD010612. doi: 10.1002/14651858.CD010612.pub3.'}]}, 'descriptionModule': {'briefSummary': 'Intervention: All patients at presentation would be assessed for the underlying cause of and will be managed by removal of all precipitants(careful review of medications, diuretics, nephrotoxic drugs,vasodilators or non-steroidal anti-inflammatory drugs). The second step would be to consider plasma volume expansion in patients with hypovolemia (the choice of fluid could either be a crystalloid or albumin or even blood as indicated) along with identification and early treatment of bacterial infections. Along with this patients with a differential diagnosis of HRS-AKI would be given terlipressin ( or noradrenaline/octreotide midodrine in case of contraindication to terlipressin). Patients with a clinical diagnosis of ATN would be randomized to the on-demand versus protocol-guided dialysis groups. Further, patients with urine output of less than 0.5ml/kg/hour for 4-6 hours despite adequate fluid resuscitation and vasoconstrictors would also be subjected to randomization.\n\n1. In the on-demand group patients would get dialysis only when patient fulfills absolute criteria requiring dialysis such as metabolic acidosis with ph\\<7.2, hyperkalemia, refractory fluid overload (non-responsive to diuretics) or oliguria with urine output of less than 0.5ml/kg for more than 24-48 hours from the time of randomization\n2. In the protocol guided group patients all patients would be considered for dialysis within 6 hours of randomization After randomization patients would receive dialysis as three sessions per week of at least 4 h with a blood flow \\>200 mL/min and a dialysate flow \\>500 mL/min in intermittent group and as 20-25 mL/kg/h of effluent, by filtration and/or diffusion in continuous form until recovery of renal functions'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with cirrhosis (diagnosed based on clinical, biochemical,radiological or histological diagnosis) with stage 3 Acute Kidney Injury defined as an increase of serum creatinine to more than 300 fold and more than 4 mg/dl.\n\nExclusion Criteria:\n\n* Patients with age less than 18 years\n* Severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD Chronic Obstructive Pulmonary Disease)\n* Pregnancy\n* Chronic kidney disease on hemodialysis\n* Patients with post renal obstructive AKI (Acute Kidney Injury), AKI (Acute Kidney Injury) suspected due to glomerulonephritis, interstitial nephritis or vasculitis based on clinical history and urine analysis\n* Patients already meeting emergency criteria for immediate hemodialysis at the time of randomization (serum potassium\\>6 meq/lt, metabolic acidosis ph\\<7.12, acute pulmonary edema, severe volume overload with hypoxemia non-responsive to diuretic treatment)\n* Patients transferred from other hospitals who have already been on hemodialysis before their arrival in the intensive care unit\n* Extremely moribund patients with an expected life expectancy of less than 24 hours\n* Failure to give informed consent from family members.\n* Hemodynamic instability requiring very high dose of vasopressors.'}, 'identificationModule': {'nctId': 'NCT02937935', 'briefTitle': 'On Demand Versus Protocol-guided Renal Replacement Therapy for Management of Stage 3 Acute Kidney Injury in Patients With Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Liver and Biliary Sciences, India'}, 'officialTitle': 'On Demand Versus Protocol-guided Renal Replacement Therapy for Management of Stage 3 Acute Kidney Injury in Patients With Cirrhosis -A Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ILBS-AKI-Cirrhosis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Protocol Guided-RRT', 'description': 'In the on-demand group patients would get dialysis only when patient fulfills absolute criteria requiring dialysis such as metabolic acidosis with ph\\<7.2, hyperkalemia, refractory fluid overload (non-responsive to diuretics) or oliguria with urine output of less than 0.5ml/kg for more than 24-48 hours from the time of randomization.', 'interventionNames': ['Biological: Protocol Guided Renal Replacement Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'On Demand-RRT', 'description': 'In the protocol guided group patients all patients would be considered for dialysis within 6 hours of randomization After randomization patients would receive dialysis as three sessions per week of at least 4 h with a blood flow \\>200 mL/min and a dialysate flow \\>500 mL/min in intermittent group and as 20-25 mL/kg/h of effluent, by filtration and/or diffusion in continuous form until recovery of renal functions', 'interventionNames': ['Biological: On Demand Renal Replacement Therapy']}], 'interventions': [{'name': 'Protocol Guided Renal Replacement Therapy', 'type': 'BIOLOGICAL', 'description': 'In the on-demand group patients would get dialysis only when patient fulfills absolute criteria requiring dialysis such as metabolic acidosis with ph\\<7.2, hyperkalemia, refractory fluid overload (non-responsive to diuretics) or oliguria with urine output of less than 0.5ml/kg for more than 24-48 hours from the time of randomization.', 'armGroupLabels': ['Protocol Guided-RRT']}, {'name': 'On Demand Renal Replacement Therapy', 'type': 'BIOLOGICAL', 'description': 'Patients to be randomized to the intervention as per standard of care', 'armGroupLabels': ['On Demand-RRT']}]}, '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}}], 'centralContacts': [{'name': 'Dr Rakhi Maiwall, MD,DM', 'role': 'CONTACT', 'email': 'rakhi_2011@yahoo.co.in', 'phone': '01146300000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Liver and Biliary Sciences, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}