ipid emulsion (drug) in Acute on Chronic Liver Failure (Liver Disease).
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Acute on Chronic Liver FailureHealth Condition 2: K746- Other and unspecified cirrhosis ofliver
- Registration Number
- CTRI/2018/04/012995
- Lead Sponsor
- Institute of liver and Biliary Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
Inclusion Criteria
1) Subjects aged 18 years and above
2) Patients tolerating enteral nutrition
3) Patients with no overt sepsis - no fever, sterile blood and urine cultures, procalcitonin <2
Exclusion Criteria
1) Active ongoing GI bleed
2) Allergy to soya oil, eggs, peanuts or other ingredients of intralipid.
3) Co-morbidities like Diabetes mellitus, hyperlipidemia, CAD and hypothyroidism.
4) Renal failure (S.creatinine > 2.5mg%)
5) Pregnancy
6) Patients with shock requiring vasopressor support
7) Patients on anticoagulants
8) Refusal to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effect of intravenous lipid emulsions (w3/ w6) on systemic inflammation and endotoxemia levels at the end of 5 days.Timepoint: 5 days
- Secondary Outcome Measures
Name Time Method Effect of lipid infusion (w3/w6) on International Normalized Ratio (INR).Timepoint: 5 days;Incidence of sepsis and related complicationsTimepoint: 28 days;Effect of lipid infusion (w3/w6) on metabolic parameters viz., serum triglyceride levels, serum ketone levels, free fatty acid levels and arterial lactate levelsTimepoint: 5 days;Effect of lipid infusion (w3/w6) on PTT (Partial Thromboplastin Time).Timepoint: 5 days;Effect of lipid infusion (w3/w6) on TEG (Thromboelastography)Timepoint: 5 days;Influence of lipid infusion (w3/w6) on nitrogen balance.Timepoint: 5 days;Influence of lipid infusion(w3/w6) on 28day mortalityTimepoint: 28 days;Oxidative stress response to lipid infusionTimepoint: 5 days