Clinical trial NCT02691533: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Liver Failure
Keywords: Acute
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2016-02-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Effect of intravenous lipid emulsions (w3/ w6) on systemic inflammation and endotoxemia levels at the end of 5 days.
timeFrame: 5 days
Secondary outcomes:
measure: Incidence of sepsis and related complications
timeFrame: 28 days
measure: Effect of lipid infusion (w3/w6) on metabolic parameters viz., serum triglyceride levels, serum ketone levels, free fatty acid levels and arterial lactate levels.
timeFrame: 5 days
measure: Influence of lipid infusion (w3/w6) on nitrogen balance.
timeFrame: 5 days
measure: Effect of lipid infusion (w3/w6) on International Normalized Ratio (INR).
timeFrame: 5 days
measure: Oxidative stress response to lipid infusion
timeFrame: 5 days
measure: Influence of lipid infusion(w3/w6) on 28day mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of liver and Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver and Biliary Sciences
name: Dr Anand Kulkarni V, MD
role: PRINCIPAL_INVESTIGATOR
References: