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

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.

Study Overview

• Status: Completed
• Conditions: Alcoholic Liver Disease
• Intervention / Treatment: Dietary supplement: Soybean based lipid emulsion

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of Liver & Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

'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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Parenteral Nutrition; Soybean based lipid emulsion	Dietary supplement: Soybean based lipid emulsion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Effect of intravenous lipid on monocytes counts.	3 days
Effect of intravenous lipid on neutrophils counts.	3 days
Effect of intravenous lipid on macrophages count.	3 days

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Influence of lipid infusion on nitrogen balance	nitrogen balance would be calculated by 24 hours urinary blood urea nitrogen estimation.	3 days
Metabolic tolerance of lipid infusion.	Metabolic tolerance would be assessed by effect on serum triglycerides level ,serum free fatty acid level,arterial lactate level.	3 days
Effect of lipid infusion on Oxidative stress.	Oxidative stress would be determine by using urinary isoprostane test.	3 days

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: February 23, 2015
• First Submitted That Met QC Criteria: March 2, 2015
• First Posted (Estimate): March 6, 2015

Study Record Updates

• Last Update Posted (Estimate): September 12, 2016
• Last Update Submitted That Met QC Criteria: September 9, 2016
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Digestive System Diseases; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol-Induced Disorders; Liver Diseases; Liver Diseases, Alcoholic
• Other Study ID Numbers: ILBS-lipid infusion-01