Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-03-01 @ 9:58 AM
Study NCT ID:
NCT02691533
Status:
COMPLETED
Last Update Posted:
2018-09-05
First Post:
2016-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Study the Immunomodulating Effects and Safety Profile of ω3 and ω6 PUFA Containing Intravenous Lipid Emulsion in Patients With Acute on Chronic Liver Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058625', 'term': 'End Stage Liver Disease'}], 'ancestors': [{'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'C545823', 'term': 'soybean oil, phospholipid emulsion'}], 'ancestors': [{'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-01', 'studyFirstSubmitDate': '2016-02-15', 'studyFirstSubmitQcDate': '2016-02-20', 'lastUpdatePostDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of intravenous lipid emulsions (w3/ w6) on systemic inflammation and endotoxemia levels at the end of 5 days.', 'timeFrame': '5 days', 'description': 'Decrease in endotoxins levels , TNF alpha,ilnterleukin 6,ilnterleukin 10,Monocyte/ macrophage activation etc.\n\nAll of them are markers of inflammation. The outcome systemic inflammation is a composite outcome which includes all the above mentioned markers'}], 'secondaryOutcomes': [{'measure': 'Incidence of sepsis and related complications', 'timeFrame': '28 days'}, {'measure': 'Effect of lipid infusion (w3/w6) on metabolic parameters viz., serum triglyceride levels, serum ketone levels, free fatty acid levels and arterial lactate levels.', 'timeFrame': '5 days', 'description': 'Metabolic parameter is a composite outcome of all the above said markers.'}, {'measure': 'Influence of lipid infusion (w3/w6) on nitrogen balance.', 'timeFrame': '5 days', 'description': 'Improvement or deterioration in urinary urea nitrogen.'}, {'measure': 'Effect of lipid infusion (w3/w6) on International Normalized Ratio (INR).', 'timeFrame': '5 days', 'description': 'Effect is defined as INR (International Normalized Ratio) value within normal limit or improvement as compare to baseline value.'}, {'measure': 'Oxidative stress response to lipid infusion', 'timeFrame': '5 days', 'description': 'Oxidative stress response is based on the Improvement or deterioration in Isoprostane levels in urine'}, {'measure': 'Influence of lipid infusion(w3/w6) on 28day mortality', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute'], 'conditions': ['Chronic Liver Failure']}, 'descriptionModule': {'briefSummary': 'Study population: Patients admitted or seen in OPD (Out Patient Department), Department of Hepatology.\n\nStudy design- Prospective Randomized Controlled Trial. Study period-January 2016 to May 2017 Intervention- Subjects will be randomized into 3 groups Group A subjects will receive ω3 PUFA (Polyunsaturated Fatty Acids) (10% Omegavan 100 ml).\n\nGroup B- will receive ω6 PUFA (Polyunsaturated Fatty Acids) (10% Intralipid 100 ml).\n\nGroup C -Placebo group\n\nMonitoring and assessment- :- The following tests will be done in these patients:-\n\n1. Complete clinical examination.\n2. Serum electrolytes- sodium, potassium, calcium, magnesium, phosphate levels\n3. BUN (Blood Urea Nitrogen)\n4. Serum free fatty acid levels\n5. Lipid profile.\n6. Arterial ammonia\n7. Arterial lactate\n8. Blood sugar and serum insulin levels'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute on Chronic Liver Failure (ACLF) patients aged 18 years and above\n* Patients tolerating enteral nutrition\n* Patients with no overt sepsis - no fever, sterile blood and urine cultures, procalcitonin \\<2\n\nExclusion Criteria:\n\n* Active ongoing GI bleed\n* Allergy to soya oil, eggs, peanuts or other ingredients of intralipid.\n* Co-morbidities like Diabetes mellitus, hyperlipidemia, CAD and hypothyroidism.\n* Renal failure (S.creatinine \\> 2.5mg%)\n* Pregnancy\n* Patients with shock requiring vasopressor support\n* Patients on anticoagulants\n* Refusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT02691533', 'briefTitle': 'To Study the Immunomodulating Effects and Safety Profile of ω3 and ω6 PUFA Containing Intravenous Lipid Emulsion in Patients With Acute on Chronic Liver Failure', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Liver and Biliary Sciences, India'}, 'officialTitle': 'To Study the Immunomodulating Effects and Safety Profile of ω3 and ω6 PUFA Containing Intravenous Lipid Emulsion in Patients With Acute on Chronic Liver Failure', 'orgStudyIdInfo': {'id': 'ILBS-ACLF-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ω3 PUFA(10% Omegavan 100 ml)', 'interventionNames': ['Drug: ω3 PUFA (Polyunsaturated fatty acids) (10% Omegavan 100 ml)']}, {'type': 'EXPERIMENTAL', 'label': 'ω6 PUFA (20% Intralipid 50 ml)', 'interventionNames': ['Drug: ω6 PUFA (Polyunsaturated fatty acids) (10% Intralipid 100 ml)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Arm', 'description': 'No Lipid Emulsion will be given in this arm', 'interventionNames': ['Drug: No Lipid Emulsion/Placebo']}], 'interventions': [{'name': 'ω3 PUFA (Polyunsaturated fatty acids) (10% Omegavan 100 ml)', 'type': 'DRUG', 'armGroupLabels': ['ω3 PUFA(10% Omegavan 100 ml)']}, {'name': 'ω6 PUFA (Polyunsaturated fatty acids) (10% Intralipid 100 ml)', 'type': 'DRUG', 'armGroupLabels': ['ω6 PUFA (20% Intralipid 50 ml)']}, {'name': 'No Lipid Emulsion/Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo Arm']}]}, '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}}], 'overallOfficials': [{'name': 'Dr Anand Kulkarni V, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Liver and Biliary Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Liver and Biliary Sciences, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}