Clinical trial NCT02381769: THE IMMUNOLOGICAL EFFECTS AND METABOLIC TOLERANCE OF LIPID INFUSION IN PATIENTS WITH CIRRHOSIS.
Official title: THE IMMUNOLOGICAL EFFECTS AND METABOLIC TOLERANCE OF LIPID INFUSION IN PATIENTS WITH CIRRHOSIS.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcoholic Liver Disease
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2015-03-06
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: '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

Primary outcomes:
measure: Effect of intravenous lipid on monocytes counts.
timeFrame: 3 days
measure: Effect of intravenous lipid on neutrophils counts.
timeFrame: 3 days
measure: Effect of intravenous lipid on macrophages count.
timeFrame: 3 days
Secondary outcomes:
measure: Influence of lipid infusion on TEG (Thromboelastography)
timeFrame: 3 days
measure: Influence of lipid infusion on TNF-α (Tumor Necrosis Factor).
timeFrame: 3 days
measure: Influence of lipid infusion on interleukin levels (IL-6, IL-10).
timeFrame: 3 days
measure: Influence of lipid infusion on PT/INR
timeFrame: 3 days
measure: Influence of lipid infusion on PTT.
timeFrame: 3 days
measure: Influence of lipid infusion on liver parameters.
timeFrame: 3 days
measure: Influence of lipid infusion on arterial ammonia.
timeFrame: 3 days
measure: Influence of lipid infusion on renal parameters.
timeFrame: 3 days
Other outcomes:
measure: Influence of lipid infusion on nitrogen balance
timeFrame: 3 days
measure: Metabolic tolerance of lipid infusion.
timeFrame: 3 days
measure: Effect of lipid infusion on Oxidative stress.
timeFrame: 3 days
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
References: