THE IMMUNOLOGICAL EFFECTS AND METABOLIC TOLERANCE OF LIPID INFUSION IN PATIENTS WITH CIRRHOSIS.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Parenteral Nutrition Soybean based lipid emulsion |
Dietary Supplement: Soybean based lipid emulsion
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Other Outcome Measures
- Influence of lipid infusion on nitrogen balance [3 days]
nitrogen balance would be calculated by 24 hours urinary blood urea nitrogen estimation.
- Metabolic tolerance of lipid infusion. [3 days]
Metabolic tolerance would be assessed by effect on serum triglycerides level ,serum free fatty acid level,arterial lactate level.
- Effect of lipid infusion on Oxidative stress. [3 days]
Oxidative stress would be determine by using urinary isoprostane test.
Eligibility Criteria
Criteria
'Inclusion Criteria:
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Subjects aged ≥ 18 years.
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Patients with alcohol related liver disease (severe alcoholic hepatitis and decompensated cirrhosis)
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Patients tolerating enteral nutrition.
Exclusion Criteria:
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Active ongoing Gastrointestinal bleed.
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Unresolved sepsis
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Allergy to soya oil, eggs, peanuts or other ingredients of intralipid.
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Co-morbidities like Diabetes mellitus, hyperlipidemia, Coronary Artery Disease (CAD) and hypothyroidism.
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Renal failure (S.creatinine > 1.5mg %)
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Pregnancy
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Patients on high inotropic support (requiring more than 1 inotropic support)
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Refusal to participate in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institute of Liver & Biliary Sciences | New Delhi | Delhi | India | 110070 |
Sponsors and Collaborators
- Institute of Liver and Biliary Sciences, India
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ILBS-lipid infusion-01