Omegaven® in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury

Wake Forest University Health Sciences11 enrolled

Overview

The purpose of this study is to determine whether the omega-3 fatty acid emulsion (Omegaven®), when used in place of the conventional soy-based fat emulsion (Intralipid), is effective in treating parenteral nutrition associated liver disease (PNALD) in children. The study hypothesis is that Omegaven® can be safely provided to children who are dependent on parenteral nutrition and have PNALD, and can reverse or prevent progression of PNALD until the child can take adequate nutrition by mouth.

Rationale for Omegaven® Treatment Unlike conventional intravenous fat emulsions, Omegaven® is comprised solely of fish oils containing primarily omega-3 fatty acids. Animal studies have shown that IV lipid emulsions such as fish oil that are high in eicosapentaenic and docosahexaenoic acid reduce impairment of bile flow as seen in cholestasis caused by conventional fat emulsions(1,2). By administering Omegaven® in place of conventional phytosterol/soybean fat emulsions, the cholestasis may be reversed and patients will be able to be maintained on adequate PN until they are able to ingest adequate nutrition enterally. References 1. Chen W. Effects of fat emulsions with different fatty acid composition on plasma and hepatic lipids in rats receiving total parenteral nutrition. Clinical Nutrition 1996;15:24. 2. Yeh S. Effects of fish oil and safflower oil emulsions on diet-induced hepatic steatosis in rats receiving total parenteral nutrition. Clinical Nutrition 1996;15:80.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Total Parenteral Nutrition-induced Cholestasis

Interventions

Omegaven®DRUG

10% Omegaven® initiated at a starting dose of 0.5g/kg/day for two days and then advancing to the goal dose of 1g/kg/day, IV (in the vein) until the patient no longer requires parenteral nutrition or until participation in the study is terminated.

Eligibility

Sex: ALLMin age: 4 WeeksMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Children 0-18 years of age * Patients will be PN-dependent and expected to continue PN for at least 30 days * Patients considered eligible for study participation must have PN-associated liver diseases . Other causes of liver disease (i.e., biliary atresia, galactosemia, alpha-1 antitrypsin deficiency) will be excluded. A liver biopsy is not necessary for treatment * Direct bilirubin \> 2.0 mg/dl * Signed patient informed consent * Signed patient assent where applicable. Exclusion Criteria: * Pregnancy * Other causes of chronic liver disease (cystic fibrosis, biliary atresia, alpha-1 antitrypsin deficiency) * Signs of advanced liver disease including cirrhosis on biopsy, varices, ascites * The patient is allergic to eggs/shellfish * The patient has a severe hemorrhagic disorder * The patient is enrolled in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team) * The parent or guardian or child unwilling to provide consent or assent.

Locations (1)

Levine Children's Hospital at Carolinas HealthCare System

Charlotte, North Carolina, United States

Outcomes

Primary Outcomes

Number of Participants With Normalization of Direct Bilirubin

Normalization of direct bilirubin is defined as less than 0.4mg/dL by 9 months. This relates to the efficacy of parenteral administration of fish oil derived fat emulsion (Omegaven®) to reverse established parenteral nutrition associated liver disease.

Time frame: Month 9

Secondary Outcomes

Number of Participants With Normal Essential Fatty Acid (EFA) Profiles.

EFA is defined at a triene tetraene ratio of greater than 0.2 (so normal is \> 0.2). Collected monthly from month 1-9.

Time frame: Months 1 through 9

Number of Participants With Triglyceride Levels > 400 mg/dL

Number of participants with triglyceride levels \> 400 mg/dL

Time frame: baseline data and then weekly and monthly evaluations, for an average of 9 months

Number of Participants With Unexpected Bleeding or Coagulopathies

Time frame: Month 6

Data from ClinicalTrials.gov

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