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Completed

NCT Number: 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

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

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Key information

Conditions

Chronic Liver Failure Digestive System Diseases End Stage Liver Disease Hepatic Insufficiency Liver Diseases Liver Failure

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ω3 PUFA (Polyunsaturated fatty acids) (10% Omegavan 100 ml)

Drug

ω6 PUFA (Polyunsaturated fatty acids) (10% Intralipid 100 ml)

Drug

No Lipid Emulsion/Placebo

Drug

Primary outcomes

  1. Effect of intravenous lipid emulsions (w3/ w6) on systemic inflammation and endotoxemia levels at the end of 5 days.

    Time frame: 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 outcomes

  1. Incidence of sepsis and related complications

    Time frame: 28 days

  2. Effect of lipid infusion (w3/w6) on metabolic parameters viz., serum triglyceride levels, serum ketone levels, free fatty acid levels and arterial lactate levels.

    Time frame: 5 days

    Metabolic parameter is a composite outcome of all the above said markers.

  3. Influence of lipid infusion (w3/w6) on nitrogen balance.

    Time frame: 5 days

    Improvement or deterioration in urinary urea nitrogen.

  4. Effect of lipid infusion (w3/w6) on International Normalized Ratio (INR).

    Time frame: 5 days

    Effect is defined as INR (International Normalized Ratio) value within normal limit or improvement as compare to baseline value.

  5. Oxidative stress response to lipid infusion

    Time frame: 5 days

    Oxidative stress response is based on the Improvement or deterioration in Isoprostane levels in urine

  6. Influence of lipid infusion(w3/w6) on 28day mortality

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 25, 2016
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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