drugset / Trial / NCT02691533

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

NCT02691533

RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2016-02-01
Primary completion
2017-12-31
Completion
2017-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Omega-3 fatty acids Unknown 100 ml Intravenous
Subject ω6 PUFA Unknown 100 ml Intravenous

Indications