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 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 Overview

• Status: Completed
• Conditions: Chronic Liver Failure
• Intervention / Treatment: Drug: ω3 PUFA (Polyunsaturated fatty acids) (10% Omegavan 100 ml); Drug: ω6 PUFA (Polyunsaturated fatty acids) (10% Intralipid 100 ml); Drug: No Lipid Emulsion/Placebo

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of liver and Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ω3 PUFA(10% Omegavan 100 ml)	Drug: ω3 PUFA (Polyunsaturated fatty acids) (10% Omegavan 100 ml)
Experimental: ω6 PUFA (20% Intralipid 50 ml)	Drug: ω6 PUFA (Polyunsaturated fatty acids) (10% Intralipid 100 ml)
Placebo Comparator: Placebo Arm; No Lipid Emulsion will be given in this arm	Drug: No Lipid Emulsion/Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India
• Investigators: Principal Investigator: Dr Anand Kulkarni V, MD, Institute of liver and Biliary Sciences

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: February 15, 2016
• First Submitted That Met QC Criteria: February 20, 2016
• First Posted (Estimate): February 25, 2016

Study Record Updates

• Last Update Posted (Actual): September 5, 2018
• Last Update Submitted That Met QC Criteria: September 1, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Acute
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Liver Failure, Acute; End Stage Liver Disease; Liver Failure; Hepatic Insufficiency; Acute-On-Chronic Liver Failure; Pharmaceutical Solutions; Parenteral Nutrition Solutions; Fat Emulsions, Intravenous; Soybean oil, phospholipid emulsion
• Other Study ID Numbers: ILBS-ACLF-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO