Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-03-01 @ 9:58 AM
Study NCT ID:
NCT02691533
Status:
COMPLETED
Last Update Posted:
2018-09-05
First Post:
2016-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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
Sponsor:
Institute of Liver and Biliary Sciences, India
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:-
1. Complete clinical examination.
2. Serum electrolytes- sodium, potassium, calcium, magnesium, phosphate levels
3. BUN (Blood Urea Nitrogen)
4. Serum free fatty acid levels
5. Lipid profile.
6. Arterial ammonia
7. Arterial lactate
8. Blood sugar and serum insulin levels
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:-
1. Complete clinical examination.
2. Serum electrolytes- sodium, potassium, calcium, magnesium, phosphate levels
3. BUN (Blood Urea Nitrogen)
4. Serum free fatty acid levels
5. Lipid profile.
6. Arterial ammonia
7. Arterial lactate
8. Blood sugar and serum insulin levels
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: