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To Study the Immunomodulating Effects and Safety Profile of ω3 and ω6 PUFA Containing Intravenous Lipid Emulsion in Patients With Acute on Chronic Liver Failure

Primary Purpose

Chronic Liver Failure

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
ω3 PUFA (Polyunsaturated fatty acids) (10% Omegavan 100 ml)
ω6 PUFA (Polyunsaturated fatty acids) (10% Intralipid 100 ml)
No Lipid Emulsion/Placebo
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Liver Failure focused on measuring Acute

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Acute on Chronic Liver Failure (ACLF) patients aged 18 years and above
  • Patients tolerating enteral nutrition
  • Patients with no overt sepsis - no fever, sterile blood and urine cultures, procalcitonin <2

Exclusion Criteria:

  • Active ongoing GI bleed
  • Allergy to soya oil, eggs, peanuts or other ingredients of intralipid.
  • Co-morbidities like Diabetes mellitus, hyperlipidemia, CAD and hypothyroidism.
  • Renal failure (S.creatinine > 2.5mg%)
  • Pregnancy
  • Patients with shock requiring vasopressor support
  • Patients on anticoagulants
  • Refusal to participate in the study

Sites / Locations

  • Institute of liver and Biliary Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

ω3 PUFA(10% Omegavan 100 ml)

ω6 PUFA (20% Intralipid 50 ml)

Placebo Arm

Arm Description

No Lipid Emulsion will be given in this arm

Outcomes

Primary Outcome Measures

Effect of intravenous lipid emulsions (w3/ w6) on systemic inflammation and endotoxemia levels at the end of 5 days.
Decrease in endotoxins levels , TNF alpha,ilnterleukin 6,ilnterleukin 10,Monocyte/ macrophage activation etc. All of them are markers of inflammation. The outcome systemic inflammation is a composite outcome which includes all the above mentioned markers

Secondary Outcome Measures

Incidence of sepsis and related complications
Effect of lipid infusion (w3/w6) on metabolic parameters viz., serum triglyceride levels, serum ketone levels, free fatty acid levels and arterial lactate levels.
Metabolic parameter is a composite outcome of all the above said markers.
Influence of lipid infusion (w3/w6) on nitrogen balance.
Improvement or deterioration in urinary urea nitrogen.
Effect of lipid infusion (w3/w6) on International Normalized Ratio (INR).
Effect is defined as INR (International Normalized Ratio) value within normal limit or improvement as compare to baseline value.
Oxidative stress response to lipid infusion
Oxidative stress response is based on the Improvement or deterioration in Isoprostane levels in urine
Influence of lipid infusion(w3/w6) on 28day mortality

Full Information

First Posted
February 15, 2016
Last Updated
September 1, 2018
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT02691533
Brief Title
To Study the Immunomodulating Effects and Safety Profile of ω3 and ω6 PUFA Containing Intravenous Lipid Emulsion in Patients With Acute on Chronic Liver Failure
Official Title
To Study the Immunomodulating Effects and Safety Profile of ω3 and ω6 PUFA Containing Intravenous Lipid Emulsion in Patients With Acute on Chronic Liver Failure
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (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
Study population: Patients admitted or seen in OPD (Out Patient Department), Department of Hepatology. Study design- Prospective Randomized Controlled Trial. Study period-January 2016 to May 2017 Intervention- Subjects will be randomized into 3 groups Group A subjects will receive ω3 PUFA (Polyunsaturated Fatty Acids) (10% Omegavan 100 ml). Group B- will receive ω6 PUFA (Polyunsaturated Fatty Acids) (10% Intralipid 100 ml). Group C -Placebo group Monitoring and assessment- :- The following tests will be done in these patients:- Complete clinical examination. Serum electrolytes- sodium, potassium, calcium, magnesium, phosphate levels BUN (Blood Urea Nitrogen) Serum free fatty acid levels Lipid profile. Arterial ammonia Arterial lactate Blood sugar and serum insulin levels

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Liver Failure
Keywords
Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ω3 PUFA(10% Omegavan 100 ml)
Arm Type
Experimental
Arm Title
ω6 PUFA (20% Intralipid 50 ml)
Arm Type
Experimental
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
No Lipid Emulsion will be given in this arm
Intervention Type
Drug
Intervention Name(s)
ω3 PUFA (Polyunsaturated fatty acids) (10% Omegavan 100 ml)
Intervention Type
Drug
Intervention Name(s)
ω6 PUFA (Polyunsaturated fatty acids) (10% Intralipid 100 ml)
Intervention Type
Drug
Intervention Name(s)
No Lipid Emulsion/Placebo
Primary Outcome Measure Information:
Title
Effect of intravenous lipid emulsions (w3/ w6) on systemic inflammation and endotoxemia levels at the end of 5 days.
Description
Decrease in endotoxins levels , TNF alpha,ilnterleukin 6,ilnterleukin 10,Monocyte/ macrophage activation etc. All of them are markers of inflammation. The outcome systemic inflammation is a composite outcome which includes all the above mentioned markers
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Incidence of sepsis and related complications
Time Frame
28 days
Title
Effect of lipid infusion (w3/w6) on metabolic parameters viz., serum triglyceride levels, serum ketone levels, free fatty acid levels and arterial lactate levels.
Description
Metabolic parameter is a composite outcome of all the above said markers.
Time Frame
5 days
Title
Influence of lipid infusion (w3/w6) on nitrogen balance.
Description
Improvement or deterioration in urinary urea nitrogen.
Time Frame
5 days
Title
Effect of lipid infusion (w3/w6) on International Normalized Ratio (INR).
Description
Effect is defined as INR (International Normalized Ratio) value within normal limit or improvement as compare to baseline value.
Time Frame
5 days
Title
Oxidative stress response to lipid infusion
Description
Oxidative stress response is based on the Improvement or deterioration in Isoprostane levels in urine
Time Frame
5 days
Title
Influence of lipid infusion(w3/w6) on 28day mortality
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute on Chronic Liver Failure (ACLF) patients aged 18 years and above Patients tolerating enteral nutrition Patients with no overt sepsis - no fever, sterile blood and urine cultures, procalcitonin <2 Exclusion Criteria: Active ongoing GI bleed Allergy to soya oil, eggs, peanuts or other ingredients of intralipid. Co-morbidities like Diabetes mellitus, hyperlipidemia, CAD and hypothyroidism. Renal failure (S.creatinine > 2.5mg%) Pregnancy Patients with shock requiring vasopressor support Patients on anticoagulants Refusal to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Anand Kulkarni V, MD
Organizational Affiliation
Institute of Liver and Biliary Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

To Study the Immunomodulating Effects and Safety Profile of ω3 and ω6 PUFA Containing Intravenous Lipid Emulsion in Patients With Acute on Chronic Liver Failure

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