Clinical Trial: 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
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: 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
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:-
- Complete clinical examination.
- Serum electrolytes- sodium, potassium, calcium, magnesium, phosphate levels
- BUN (Blood Urea Nitrogen)
- Serum free fatty acid levels
- Lipid profile.
- Arterial ammonia
- Arterial lactate
- Blood sugar and serum insulin levels
Detailed Summary:
Sponsor: Institute of Liver and Biliary Sciences, India
Current Primary Outcome: Effect of intravenous lipid emulsions (w3/ w6) on systemic inflammation and endotoxemia levels at the end of 5 days. [ Time Frame: 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
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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. [ Time Frame: 5 days ]Metabolic parameter is a composite outcome of all the above said markers.
- Influence of lipid infusion (w3/w6) on nitrogen balance. [ Time Frame: 5 days ]Improvement or deterioration in urinary urea nitrogen.
- Effect of lipid infusion (w3/w6) on International Normalized Ratio (INR). [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 28 days ]
Original Secondary Outcome:
- 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. [ Time Frame: 5 days ]Metabolic parameter is a composite outcome of all the above said markers.
- Influence of lipid infusion (w3/w6) on nitrogen balance. [ Time Frame: 5 days ]Improvement or deterioration in urinary urea nitrogen.
- Effect of lipid infusion (w3/w6) on International Normalized Ratio (INR). [ Time Frame: 5 days ]Effect is defined as INR (International Normalized Ratio) value within normal limit or improvement as compare to baseline value.
- Effect of lipid infusion (w3/w6) on TEG (Thromboelastography). [ Time Frame: 5 days ]Effect is defined as TEG value within normal limit or improvement as compare to baseline value.
- Effect of lipid infusion (w3/w6) on PTT (Partial Thromboplastin Time). [ Time Frame: 5 days ]Effect is defined as PTT value within normal limit or improvement as compare to baseline value.
- Oxidative stress response to lipid infusion [ Time Frame: 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 [ Time Frame: 28 days ]
Information By: Institute of Liver and Biliary Sciences, India
Dates:
Date Received: February 15, 2016
Date Started: February 2016
Date Completion: December 2017
Last Updated: March 15, 2017
Last Verified: January 2017