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

NCT02381769 | Completed

• 1 other identifier: ILBS-lipid infusion-01
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• 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

Other Outcomes (3)

• Influence of lipid infusion on nitrogen balance

  3 days

• Metabolic tolerance of lipid infusion.

  3 days

• Effect of lipid infusion on Oxidative stress.

  3 days

Study Arms (1)

Parenteral Nutrition

EXPERIMENTAL

Soybean based lipid emulsion

Dietary Supplement: Soybean based lipid emulsion

Interventions

Soybean based lipid emulsion DIETARY_SUPPLEMENT

Parenteral Nutrition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Liver Diseases, Alcoholic

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: March 6, 2015
• Study Start: June 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 12, 2016

Record last verified: 2014-12

Locations

IN (1)