An interventional study of ω3 PUFA (Polyunsaturated fatty acids) (10% Omegavan 100 ml) and ω6 PUFA (Polyunsaturated fatty acids) (10% Intralipid 100 ml) in Chronic Liver Failure, sponsored by Institute of Liver and Biliary Sciences, India. Completed at 1 site in India. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-09-05.
Sponsored by Institute of Liver and Biliary Sciences, India · Not applicable, Interventional, and Treatment
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:-
445 studies on the registry are indexed under Liver Failure; 69 are open to participants now.
This study's enrollment of 90 is above the median of 43 across 276 interventional studies indexed under Liver Failure.
Browse Liver Failure studies →Institute of Liver and Biliary Sciences, India is the lead sponsor of 296 studies on the registry; 84 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: ω3 PUFA (Polyunsaturated fatty acids) (10% Omegavan 100 ml)
Drug: ω6 PUFA (Polyunsaturated fatty acids) (10% Intralipid 100 ml)
No Lipid Emulsion will be given in this arm
Drug: No Lipid Emulsion/Placebo
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
Plan to share: No
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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Institute of Liver and Biliary Sciences, India