Evaluation of OMEGAVEN 10%® (n-3 EFA Lipid Emulsion) in Home Parenteral Nutrition-associated Liver Disease

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the study is to show that substitution of the usual lipid emulsion (Intralipid 20%®) at a dose between 0.5 and 1.0 g/kg/infusion of parenteral nutrition (n-6:n-3 ratio = 7:1) by an equivalent dose of 0.5 to 1 g/kg/infusion of another lipid emulsion, OMEGAVEN 10%® very rich in omega-3 (n-3) (n-6:n-3 ratio = 1:7) induces regression of PNALD due to the anti-inflammatory and anti-fibrotic effects of n-3 EFA.

Regression of liver disease will be defined by normalization of the five liver function tests (LFT): conjugated bilirubin, gamma GT, alkaline phosphatase, AST and ALT transaminases.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Soybean oil, phospholipid emulsion; Vitamin E

Criteria

Inclusion Criteria:

• Age greater than or equal to 18 years.

• Patients on HPN for chronic benign intestinal failure:

with a degree of HPN dependence ≥ two cycles of PN per week with at least one ternary infusion (comprising lipids) per week with a maximum lipid intake of 40 grams per ternary infusion

• Expected duration of HPN dependence greater than 18 weeks at the time of inclusion.

• Receiving HPN for at least 12 weeks in one of the three study centres, which is a sufficient period to allow resolution of any drug-induced or septic cholestasis and cytolysis related to a previous hospitalisation.

• Presence of PNALD, defined by an abnormality of at least two of the five liver function tests performed (conjugated bilirubin, gamma glutamyltransferase, alkaline phosphatase, AST, ALT).

• Stable patient with no infection during the six weeks preceding inclusion.

• Medical examination performed before inclusion.

• Written informed consent.

• Covered by French national health insurance.

Exclusion Criteria:

• Active cancer, regardless of the primary site.

• Uncontrolled cardiopulmonary insufficiency.

• Decompensated cirrhosis.

• Severe renal failure.

• Uncontrolled diabetes or endocrinopathy.

• Hyperlipoproteinaemia and hypertriglyceridaemia (≥ 3 mmol/L).

• Other causes of liver disease (biliary obstruction, alcohol, hepatitis B virus, hepatitis C virus, CMV, hepatotoxic drugs).

• Systemic corticosteroid therapy or biotherapy (anti-TNF).

• Pregnant women or nursing mothers.

• Inclusion in another study terminated or less than three months.

• Known allergy to fish or egg proteins.