Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2025-12-28 @ 12:51 PM
Study NCT ID:
NCT02937961
Status:
UNKNOWN
Last Update Posted:
2019-03-07
First Post:
2016-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Versus Late Sustained Low Efficiency Dialysis in Critically Ill Cirrhotics With Septic Shock and Acute Kidney Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-04', 'studyFirstSubmitDate': '2016-10-17', 'studyFirstSubmitQcDate': '2016-10-17', 'lastUpdatePostDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Transplant free survival in both groups', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'Incidence of intradialytic hypotension in both groups', 'timeFrame': '48 hours'}, {'measure': 'Hemodynamic stability in both groups', 'timeFrame': '48 hours'}, {'measure': 'Dialysis efficiency as measured by Urea Reduction ratio in both groups', 'timeFrame': '2 days'}, {'measure': 'Achievement of target ultrafiltration goals in both groups', 'timeFrame': '48 hours'}, {'measure': 'Recovery in renal functions in both groups', 'timeFrame': '14 days', 'description': 'Recovery is defined as an increase in urine output to more than 400 ml/day'}, {'measure': 'Duration of Intensive Care Unit stay in both groups', 'timeFrame': '28 days'}, {'measure': 'Duration of mechanical ventilation in both groups', 'timeFrame': '28 days'}, {'measure': 'Improvement in Sequential Organ Failure Assessment ( by 2 points) scores in both groups', 'timeFrame': '28 days'}, {'measure': 'Improvement in SOFA, Model for End stage Liver Disease ( by 2 points) scores', 'timeFrame': '28 days'}, {'measure': 'Improvement in Acute Physiology and Chronic Health Evaluation ( by 2 points) scores', 'timeFrame': '28 days'}, {'measure': 'Improvement in lactic acidosis and lactate clearance at 6 initiation of dialysis in both groups', 'timeFrame': '6 hours'}, {'measure': 'Improvement in lactic acidosis and lactate clearance at 24 hours after initiation of dialysis in both groups', 'timeFrame': '12 hours'}, {'measure': 'Improvement in lactic acidosis and lactate clearance at 24 hours after initiation of dialysis in both groups', 'timeFrame': '24 hours'}, {'measure': 'Death related with renal failure in both groups', 'timeFrame': '7 day'}, {'measure': 'Mortality due to renal failure related in both groups.', 'timeFrame': '7 day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cirrhotics With Septic Shock and Acute Kidney Injury']}, 'referencesModule': {'references': [{'pmid': '41020192', 'type': 'DERIVED', 'citation': 'Maiwall R, Pasupuleti SSR, Agarwal P, Thomas S, Tevethia HV, Mathur RP, Sarin SK. Early Versus Late Dialysis in Cirrhosis Patients and Septic Shock (ELDICS Study): A Randomized Controlled Trial (NCT02937961). JGH Open. 2025 Sep 24;9(9):e70216. doi: 10.1002/jgh3.70216. eCollection 2025 Sep.'}, {'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': 'Consecutive patients with cirrhosis and septic shock with AKI who give written informed consent will be included in this prospective trial. At baseline NT-Pro BNP, urine N-GAL will be done for all patients. A baseline serum blood sample (10 ml) and urine sample will be stored. Septic shock will be defined by the presence of two or more diagnostic criteria for the systemic inflammatory response syndrome, proven or suspected infection with hypotension non-responsive to adequate fluid resuscitation assessed by no evidence of stroke volume variation on flow track and need of a vasopressor to achieve a target mean arterial pressure (MAP) of ≥ 65 mm Hg. A record of CVP, IVC diameter and B-lines on ultrasound lung would also be done. Patients with age less than 18 years, severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD) pregnancy, chronic kidney disease on hemodialysis, patients already meeting emergency criteria for immediate hemodialysis at the time of randomization as specified in the late group, patients transferred from other hospitals who have already been on hemodialysis before their arrival in the intensive care unit, extremely moribund patients with an expected life expectancy of less than 24 hours, failure to give informed consent from family members.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients with Cirrhosis with septic shock associated AKI (Acute Kidney Injury) stage 3 AKIN/KDIGO stage 2.\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, Coronary Obstructive Pulmonary Disease)\n* Pregnancy\n* Chronic kidney disease on hemodialysis\n* Patients with Hepatorenal Syndrome, post renal obstructive AKI, AKI due to suspected based on history,urinalysis and past clinical records-glomerulonephritis, interstitial nephritis or vasculitis\n* Patients already meeting emergency criteria for immediate hemodialysis at the time of randomization as specified in the late group (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': 'NCT02937961', 'briefTitle': 'Early Versus Late Sustained Low Efficiency Dialysis in Critically Ill Cirrhotics With Septic Shock and Acute Kidney Injury', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Liver and Biliary Sciences, India'}, 'officialTitle': 'Early Versus Late Sustained Low Efficiency Dialysis in Critically Ill Cirrhotics With Septic Shock and Acute Kidney Injury -A Pilot Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ILBS-Septic Shock-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early SLED', 'interventionNames': ['Biological: Early SLED']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Late SLED', 'interventionNames': ['Biological: Late SLED']}], 'interventions': [{'name': 'Early SLED', 'type': 'BIOLOGICAL', 'description': 'withing 6 to 12 hours', 'armGroupLabels': ['Early SLED']}, {'name': 'Late SLED', 'type': 'BIOLOGICAL', 'description': 'when absolute indications will meet', 'armGroupLabels': ['Late SLED']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110070', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'status': 'RECRUITING', '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'}}}}