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
- Conditions
- Chronic Liver Failure
- Interventions
- Drug: ω3 PUFA (Polyunsaturated fatty acids) (10% Omegavan 100 ml)Drug: ω6 PUFA (Polyunsaturated fatty acids) (10% Intralipid 100 ml)
- Registration Number
- NCT02691533
- Lead Sponsor
- Institute of Liver and Biliary Sciences, India
- Brief Summary
Study population: Patients admitted or seen in OPD (Out Patient Department), Department of Hepatology.
Study 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).
Group B- will receive ω6 PUFA (Polyunsaturated Fatty Acids) (10% Intralipid 100 ml).
Group C -Placebo group
Monitoring and assessment- :- The following tests will be done in these patients:-
1. Complete clinical examination.
2. Serum electrolytes- sodium, potassium, calcium, magnesium, phosphate levels
3. BUN (Blood Urea Nitrogen)
4. Serum free fatty acid levels
5. Lipid profile.
6. Arterial ammonia
7. Arterial lactate
8. Blood sugar and serum insulin levels
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- Acute on Chronic Liver Failure (ACLF) patients aged 18 years and above
- Patients tolerating enteral nutrition
- Patients with no overt sepsis - no fever, sterile blood and urine cultures, procalcitonin <2
- Active ongoing GI bleed
- Allergy to soya oil, eggs, peanuts or other ingredients of intralipid.
- Co-morbidities like Diabetes mellitus, hyperlipidemia, CAD and hypothyroidism.
- Renal failure (S.creatinine > 2.5mg%)
- Pregnancy
- Patients with shock requiring vasopressor support
- Patients on anticoagulants
- Refusal to participate in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ω3 PUFA(10% Omegavan 100 ml) ω3 PUFA (Polyunsaturated fatty acids) (10% Omegavan 100 ml) - ω6 PUFA (20% Intralipid 50 ml) ω6 PUFA (Polyunsaturated fatty acids) (10% Intralipid 100 ml) - Placebo Arm No Lipid Emulsion/Placebo No Lipid Emulsion will be given in this arm
- 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. 5 days Decrease in endotoxins levels , TNF alpha,ilnterleukin 6,ilnterleukin 10,Monocyte/ macrophage activation etc.
All of them are markers of inflammation. The outcome systemic inflammation is a composite outcome which includes all the above mentioned markers
- Secondary Outcome Measures
Name Time Method Incidence of sepsis and related complications 28 days Influence of lipid infusion (w3/w6) on nitrogen balance. 5 days Improvement or deterioration in urinary urea nitrogen.
Effect of lipid infusion (w3/w6) on International Normalized Ratio (INR). 5 days Effect is defined as INR (International Normalized Ratio) value within normal limit or improvement as compare to baseline value.
Oxidative stress response to lipid infusion 5 days Oxidative stress response is based on the Improvement or deterioration in Isoprostane levels in urine
Influence of lipid infusion(w3/w6) on 28day mortality 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 levels. 5 days Metabolic parameter is a composite outcome of all the above said markers.
Trial Locations
- Locations (1)
Institute of liver and Biliary Sciences
🇮🇳New Delhi, Delhi, India