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

Not Applicable

Completed

• Conditions: Alcoholic Liver Disease
• Interventions: Dietary Supplement: Soybean based lipid emulsion

• Registration Number: NCT02381769
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Status Verified: 2014-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Study First Submitted: 2015-02-23
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-06
• Last Update Submitted: 2016-09-09
• Last Update Posted: 2016-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Parenteral Nutrition	Soybean based lipid emulsion	Soybean based lipid emulsion

Primary Outcome Measures

Name	Time	Method
Effect of intravenous lipid on macrophages count.	3 days
Effect of intravenous lipid on monocytes counts.	3 days
Effect of intravenous lipid on neutrophils counts.	3 days

Secondary Outcome Measures

Name	Time	Method
Influence of lipid infusion on PTT.	3 days
Influence of lipid infusion on arterial ammonia.	3 days
Influence of lipid infusion on TNF-α (Tumor Necrosis Factor).	3 days
Influence of lipid infusion on PT/INR	3 days
Influence of lipid infusion on liver parameters.	3 days
Influence of lipid infusion on renal parameters.	3 days
Influence of lipid infusion on interleukin levels (IL-6, IL-10).	3 days
Influence of lipid infusion on TEG (Thromboelastography)	3 days

Trial Locations

Locations (1)

Institute of Liver & Biliary Sciences; 🇮🇳 New Delhi, Delhi, India