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

Alcoholic Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02381769
• Other study ID #: ILBS-lipid infusion-01
• Status: Completed
• Phase: N/A
• First received: February 23, 2015
• Last updated: September 9, 2016
• Start date: June 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

`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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Alcoholic Liver Disease
• Fibrosis
• Liver Diseases
• Liver Diseases, Alcoholic

Intervention

Dietary Supplement:
• Soybean based lipid emulsion

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Influence of lipid infusion on nitrogen balance	nitrogen balance would be calculated by 24 hours urinary blood urea nitrogen estimation.	3 days	No
Other	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	No
Other	Effect of lipid infusion on Oxidative stress.	Oxidative stress would be determine by using urinary isoprostane test.	3 days	No
Primary	Effect of intravenous lipid on monocytes counts.		3 days	No
Primary	Effect of intravenous lipid on neutrophils counts.		3 days	No
Primary	Effect of intravenous lipid on macrophages count.		3 days	No
Secondary	Influence of lipid infusion on TEG (Thromboelastography)		3 days	No
Secondary	Influence of lipid infusion on TNF-a (Tumor Necrosis Factor).		3 days	No
Secondary	Influence of lipid infusion on interleukin levels (IL-6, IL-10).		3 days	No
Secondary	Influence of lipid infusion on PT/INR		3 days	No
Secondary	Influence of lipid infusion on PTT.		3 days	No
Secondary	Influence of lipid infusion on liver parameters.		3 days	No
Secondary	Influence of lipid infusion on arterial ammonia.		3 days	No
Secondary	Influence of lipid infusion on renal parameters.		3 days	No