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

NCT ID: NCT02381769

Last Updated: 2016-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-12-31

Brief Summary

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.

Conditions

Alcoholic Liver Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Parenteral Nutrition

Soybean based lipid emulsion

Group Type: EXPERIMENTAL

Soybean based lipid emulsion

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Soybean based lipid emulsion

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Countries

India

Other Identifiers

ILBS-lipid infusion-01

Identifier Type: -

Identifier Source: org_study_id