THE IMMUNOLOGICAL EFFECTS AND METABOLIC TOLERANCE OF LIPID INFUSION IN PATIENTS WITH CIRRHOSIS.
Primary Purpose
Alcoholic Liver Disease
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Soybean based lipid emulsion
Sponsored by
About this trial
This is an interventional supportive care trial for Alcoholic Liver Disease
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
Sites / Locations
- Institute of Liver & Biliary Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Parenteral Nutrition
Arm Description
Soybean based lipid emulsion
Outcomes
Primary Outcome Measures
Effect of intravenous lipid on monocytes counts.
Effect of intravenous lipid on neutrophils counts.
Effect of intravenous lipid on macrophages count.
Secondary Outcome Measures
Influence of lipid infusion on TEG (Thromboelastography)
Influence of lipid infusion on TNF-α (Tumor Necrosis Factor).
Influence of lipid infusion on interleukin levels (IL-6, IL-10).
Influence of lipid infusion on PT/INR
Influence of lipid infusion on PTT.
Influence of lipid infusion on liver parameters.
Influence of lipid infusion on arterial ammonia.
Influence of lipid infusion on renal parameters.
Full Information
NCT ID
NCT02381769
First Posted
February 23, 2015
Last Updated
September 9, 2016
Sponsor
Institute of Liver and Biliary Sciences, India
1. Study Identification
Unique Protocol Identification Number
NCT02381769
Brief Title
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
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholic Liver Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parenteral Nutrition
Arm Type
Experimental
Arm Description
Soybean based lipid emulsion
Intervention Type
Dietary Supplement
Intervention Name(s)
Soybean based lipid emulsion
Primary Outcome Measure Information:
Title
Effect of intravenous lipid on monocytes counts.
Time Frame
3 days
Title
Effect of intravenous lipid on neutrophils counts.
Time Frame
3 days
Title
Effect of intravenous lipid on macrophages count.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Influence of lipid infusion on TEG (Thromboelastography)
Time Frame
3 days
Title
Influence of lipid infusion on TNF-α (Tumor Necrosis Factor).
Time Frame
3 days
Title
Influence of lipid infusion on interleukin levels (IL-6, IL-10).
Time Frame
3 days
Title
Influence of lipid infusion on PT/INR
Time Frame
3 days
Title
Influence of lipid infusion on PTT.
Time Frame
3 days
Title
Influence of lipid infusion on liver parameters.
Time Frame
3 days
Title
Influence of lipid infusion on arterial ammonia.
Time Frame
3 days
Title
Influence of lipid infusion on renal parameters.
Time Frame
3 days
Other Pre-specified Outcome Measures:
Title
Influence of lipid infusion on nitrogen balance
Description
nitrogen balance would be calculated by 24 hours urinary blood urea nitrogen estimation.
Time Frame
3 days
Title
Metabolic tolerance of lipid infusion.
Description
Metabolic tolerance would be assessed by effect on serum triglycerides level ,serum free fatty acid level,arterial lactate level.
Time Frame
3 days
Title
Effect of lipid infusion on Oxidative stress.
Description
Oxidative stress would be determine by using urinary isoprostane test.
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Institute of Liver & Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
12. IPD Sharing Statement
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THE IMMUNOLOGICAL EFFECTS AND METABOLIC TOLERANCE OF LIPID INFUSION IN PATIENTS WITH CIRRHOSIS.
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