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

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Chronic Liver Failure

Treatments: Drug: No Lipid Emulsion/Placebo; Drug: ω3 PUFA (Polyunsaturated fatty acids) (10% Omegavan 100 ml); Drug: ω6 PUFA (Polyunsaturated fatty acids) (10% Intralipid 100 ml)

Study type: Interventional

Funder types: Other

Identifiers

NCT02691533

ILBS-ACLF-006

Details and patient eligibility

About

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

Enrollment: 90 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups, including a placebo group

ω3 PUFA(10% Omegavan 100 ml)

Experimental group

Treatment:

Drug: ω3 PUFA (Polyunsaturated fatty acids) (10% Omegavan 100 ml)

ω6 PUFA (20% Intralipid 50 ml)

Experimental group

Treatment:

Drug: ω6 PUFA (Polyunsaturated fatty acids) (10% Intralipid 100 ml)

Placebo Arm

Placebo Comparator group

Description:

No Lipid Emulsion will be given in this arm

Treatment:

Drug: No Lipid Emulsion/Placebo