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:-

  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 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