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

• Status: Completed
• Trial end date: 2017-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Liver and Biliary Sciences, India
• Treatments: Fat Emulsions, Intravenous; Soybean oil, phospholipid emulsion

Criteria

Inclusion Criteria:

• Acute on Chronic Liver Failure (ACLF) patients aged 18 years and above

• Patients tolerating enteral nutrition

• Patients with no overt sepsis - no fever, sterile blood and urine cultures, procalcitonin <2

Exclusion Criteria:

• Active ongoing GI bleed

• Allergy to soya oil, eggs, peanuts or other ingredients of intralipid.

• Co-morbidities like Diabetes mellitus, hyperlipidemia, CAD and hypothyroidism.

• Renal failure (S.creatinine > 2.5mg%)

• Pregnancy

• Patients with shock requiring vasopressor support

• Patients on anticoagulants

• Refusal to participate in the study