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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Institute of liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Effect of intravenous lipid emulsions (w3/ w6) on systemic inflammation and endotoxemia levels at the end of 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
Time frame: 5 days
Incidence of sepsis and related complications
Time frame: 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.
Metabolic parameter is a composite outcome of all the above said markers.
Time frame: 5 days
Influence of lipid infusion (w3/w6) on nitrogen balance.
Improvement or deterioration in urinary urea nitrogen.
Time frame: 5 days
Effect of lipid infusion (w3/w6) on International Normalized Ratio (INR).
Effect is defined as INR (International Normalized Ratio) value within normal limit or improvement as compare to baseline value.
Time frame: 5 days
Oxidative stress response to lipid infusion
Oxidative stress response is based on the Improvement or deterioration in Isoprostane levels in urine
Time frame: 5 days
Influence of lipid infusion(w3/w6) on 28day mortality
Time frame: 28 days
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