Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-02-25 @ 8:31 PM
Study NCT ID:
NCT02381769
Status:
COMPLETED
Last Update Posted:
2016-09-12
First Post:
2015-02-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
THE IMMUNOLOGICAL EFFECTS AND METABOLIC TOLERANCE OF LIPID INFUSION IN PATIENTS WITH CIRRHOSIS.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008108', 'term': 'Liver Diseases, Alcoholic'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D020751', 'term': 'Alcohol-Induced Disorders'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-09', 'studyFirstSubmitDate': '2015-02-23', 'studyFirstSubmitQcDate': '2015-03-02', 'lastUpdatePostDateStruct': {'date': '2016-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Influence of lipid infusion on nitrogen balance', 'timeFrame': '3 days', 'description': 'nitrogen balance would be calculated by 24 hours urinary blood urea nitrogen estimation.'}, {'measure': 'Metabolic tolerance of lipid infusion.', 'timeFrame': '3 days', 'description': 'Metabolic tolerance would be assessed by effect on serum triglycerides level ,serum free fatty acid level,arterial lactate level.'}, {'measure': 'Effect of lipid infusion on Oxidative stress.', 'timeFrame': '3 days', 'description': 'Oxidative stress would be determine by using urinary isoprostane test.'}], 'primaryOutcomes': [{'measure': 'Effect of intravenous lipid on monocytes counts.', 'timeFrame': '3 days'}, {'measure': 'Effect of intravenous lipid on neutrophils counts.', 'timeFrame': '3 days'}, {'measure': 'Effect of intravenous lipid on macrophages count.', 'timeFrame': '3 days'}], 'secondaryOutcomes': [{'measure': 'Influence of lipid infusion on TEG (Thromboelastography)', 'timeFrame': '3 days'}, {'measure': 'Influence of lipid infusion on TNF-α (Tumor Necrosis Factor).', 'timeFrame': '3 days'}, {'measure': 'Influence of lipid infusion on interleukin levels (IL-6, IL-10).', 'timeFrame': '3 days'}, {'measure': 'Influence of lipid infusion on PT/INR', 'timeFrame': '3 days'}, {'measure': 'Influence of lipid infusion on PTT.', 'timeFrame': '3 days'}, {'measure': 'Influence of lipid infusion on liver parameters.', 'timeFrame': '3 days'}, {'measure': 'Influence of lipid infusion on arterial ammonia.', 'timeFrame': '3 days'}, {'measure': 'Influence of lipid infusion on renal parameters.', 'timeFrame': '3 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Alcoholic Liver Disease']}, 'descriptionModule': {'briefSummary': "The study will be an experimental pre-post trial in which patients with ethanol related liver disease (both severe alcoholic hepatitis and decompensated ) admitted in our institute from Jun 2013-Dec 2014 will be enrolled in the study. Those on ryle's tube feeding would receive polymeric blenderized kitchen based liquid diet while those tolerating orally would receive soft/ solid diet as tolerated as per requirement. All the patients would receive same amount of calories i.e., 30-35 kcal/kg ideal body weight/ day and 1-1.2 gm/kg protein. 35-40% of non protein calorie would be provided as fats and rest of the calories will be provided as carbohydrates. All patients will be transfused 250ml of 20% intra lipid per day for 3 consecutive days, over and above the feed provided to them to be taken enterally (orally or through Ryle's Tube). Patients will undergo tests prior to infusion and 72 hours after infusion."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "'Inclusion Criteria:\n\n* Subjects aged ≥ 18 years.\n* Patients with alcohol related liver disease (severe alcoholic hepatitis and decompensated cirrhosis)\n* Patients tolerating enteral nutrition.\n\nExclusion Criteria:\n\n* Active ongoing Gastrointestinal bleed.\n* Unresolved sepsis\n* Allergy to soya oil, eggs, peanuts or other ingredients of intralipid.\n* Co-morbidities like Diabetes mellitus, hyperlipidemia, Coronary Artery Disease (CAD) and hypothyroidism.\n* Renal failure (S.creatinine \\> 1.5mg %)\n* Pregnancy\n* Patients on high inotropic support (requiring more than 1 inotropic support)\n* Refusal to participate in the study"}, 'identificationModule': {'nctId': 'NCT02381769', 'briefTitle': 'THE IMMUNOLOGICAL EFFECTS AND METABOLIC TOLERANCE OF LIPID INFUSION IN PATIENTS WITH CIRRHOSIS.', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Liver and Biliary Sciences, India'}, 'officialTitle': 'THE IMMUNOLOGICAL EFFECTS AND METABOLIC TOLERANCE OF LIPID INFUSION IN PATIENTS WITH CIRRHOSIS.', 'orgStudyIdInfo': {'id': 'ILBS-lipid infusion-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Parenteral Nutrition', 'description': 'Soybean based lipid emulsion', 'interventionNames': ['Dietary Supplement: Soybean based lipid emulsion']}], 'interventions': [{'name': 'Soybean based lipid emulsion', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Parenteral Nutrition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110070', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'Institute of Liver & Biliary Sciences', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Liver and Biliary Sciences, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}