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

Chronic Liver Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02691533
• Other study ID #: ILBS-ACLF-006
• Status: Completed
• Phase: N/A
• Start date: February 1, 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: February 2018
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute-On-Chronic Liver Failure
• Chronic Liver Failure
• End Stage Liver Disease
• Liver Failure

Intervention

Drug:
• ?3 PUFA (Polyunsaturated fatty acids) (10% Omegavan 100 ml)

• ?6 PUFA (Polyunsaturated fatty acids) (10% Intralipid 100 ml)

• No Lipid Emulsion/Placebo

Locations

Country	Name	City	State
India	Institute of liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	5 days
Secondary	Incidence of sepsis and related complications		28 days
Secondary	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.	5 days
Secondary	Influence of lipid infusion (w3/w6) on nitrogen balance.	Improvement or deterioration in urinary urea nitrogen.	5 days
Secondary	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.	5 days
Secondary	Oxidative stress response to lipid infusion	Oxidative stress response is based on the Improvement or deterioration in Isoprostane levels in urine	5 days
Secondary	Influence of lipid infusion(w3/w6) on 28day mortality		28 days