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Completed

NCT Number: NCT02381769

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.

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Key information

Conditions

Alcoholic Liver Disease Alcohol-Induced Disorders Alcohol-Related Disorders Chemically-Induced Disorders Digestive System Diseases Liver Diseases Liver Diseases, Alcoholic Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Liver & Biliary Sciences

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

'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

Treatment and study plan

Soybean based lipid emulsion

Dietary Supplement

Primary outcomes

  1. Effect of intravenous lipid on monocytes counts.

    Time frame: 3 days

  2. Effect of intravenous lipid on neutrophils counts.

    Time frame: 3 days

  3. Effect of intravenous lipid on macrophages count.

    Time frame: 3 days

Secondary outcomes

  1. Influence of lipid infusion on TEG (Thromboelastography)

    Time frame: 3 days

  2. Influence of lipid infusion on TNF-α (Tumor Necrosis Factor).

    Time frame: 3 days

  3. Influence of lipid infusion on interleukin levels (IL-6, IL-10).

    Time frame: 3 days

  4. Influence of lipid infusion on PT/INR

    Time frame: 3 days

  5. Influence of lipid infusion on PTT.

    Time frame: 3 days

  6. Influence of lipid infusion on liver parameters.

    Time frame: 3 days

  7. Influence of lipid infusion on arterial ammonia.

    Time frame: 3 days

  8. Influence of lipid infusion on renal parameters.

    Time frame: 3 days

Other outcomes

  1. Influence of lipid infusion on nitrogen balance

    Time frame: 3 days

    nitrogen balance would be calculated by 24 hours urinary blood urea nitrogen estimation.

  2. Metabolic tolerance of lipid infusion.

    Time frame: 3 days

    Metabolic tolerance would be assessed by effect on serum triglycerides level ,serum free fatty acid level,arterial lactate level.

  3. Effect of lipid infusion on Oxidative stress.

    Time frame: 3 days

    Oxidative stress would be determine by using urinary isoprostane test.

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 6, 2015
Registry last updated
Sep 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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