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

Study Overview
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Brief Summary
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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.

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

Conditions
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Alcoholic Liver Disease

Intervention / Treatment
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* Dietary Supplement: Soybean based lipid emulsion


Participation Criteria
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Eligibility Criteria
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'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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parenteral Nutrition<br>Soybean based lipid emulsion | Dietary Supplement: Soybean based lipid emulsion<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |