THE IMMUNOLOGICAL EFFECTS AND METABOLIC TOLERANCE OF LIPID INFUSION IN PATIENTS WITH CIRRHOSIS.

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Alcoholic Liver Disease

Treatments: Dietary Supplement: Soybean based lipid emulsion

Study type: Interventional

Funder types: Other

Identifiers

NCT02381769

ILBS-lipid infusion-01

Details and patient eligibility

About

The study will be an experimental pre-post trial in which patients with ethanol related liver disease (both severe alcoholic hepatitis and decompensated ) admitted in our institute from Jun 2013-Dec 2014 will be enrolled in the study. Those on ryle's tube feeding would receive polymeric blenderized kitchen based liquid diet while those tolerating orally would receive soft/ solid diet as tolerated as per requirement. All the patients would receive same amount of calories i.e., 30-35 kcal/kg ideal body weight/ day and 1-1.2 gm/kg protein. 35-40% of non protein calorie would be provided as fats and rest of the calories will be provided as carbohydrates. All patients will be transfused 250ml of 20% intra lipid per day for 3 consecutive days, over and above the feed provided to them to be taken enterally (orally or through Ryle's Tube). Patients will undergo tests prior to infusion and 72 hours after infusion.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

'Inclusion Criteria:

• Subjects aged ≥ 18 years.
• Patients with alcohol related liver disease (severe alcoholic hepatitis and decompensated cirrhosis)
• Patients tolerating enteral nutrition.

Exclusion Criteria:

• Active ongoing Gastrointestinal bleed.
• Unresolved sepsis
• Allergy to soya oil, eggs, peanuts or other ingredients of intralipid.
• Co-morbidities like Diabetes mellitus, hyperlipidemia, Coronary Artery Disease (CAD) and hypothyroidism.
• Renal failure (S.creatinine > 1.5mg %)
• Pregnancy
• Patients on high inotropic support (requiring more than 1 inotropic support)
• Refusal to participate in the study

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Parenteral Nutrition

Experimental group

Description:

Soybean based lipid emulsion

Treatment:

Dietary Supplement: Soybean based lipid emulsion