Omegaven Treatment of Parenteral Nutrition (PN) Induced Liver Injury

• Status: Completed
• Trial end date: 2019-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study examines the hypothesis that administering intravenous fish oil, in lieu of intravenous soybean oil, can ameliorate the progression of PN-associated cholestatic liver disease in pediatric patients with elevated direct bilirubin requiring PN for more than 30 days.

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

Details

• Lead Sponsor: Children's Hospital Los Angeles

Criteria

Inclusion Criteria:

• Patients will be parenteral nutrition dependent and are expected to require PN for at least another 30 days

• Patients must have parenteral nutrition associated liver disease (PNALD) as defined by having at least 2 consecutive direct bilirubins >2 mg/dl.

Exclusion Criteria:

• Pregnancy

• Other causes of liver disease

• Enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)

• Direct bilirubin < 2 mg/dl

• Allergy to any fish product, egg protein, and/or previous allergy to Omegaven

• Active coagulopathy characterized by on-going bleeding or acute need for clotting factor replacement such as FFP or cryoprecipitate to maintain homeostasis

• Impaired lipid metabolism as defined by serum Tg level >400 at time of initiation of Omegaven

• Unstable diabetes mellitus

• Recent stroke/embolism, not including catheter related thrombosis, which is a common complication of central venous catheter.

• Collapse and shock

• Undefined coma status

• Untreated infection at time of initiation of Omegaven

• Hemodynamic instability

• > 21 years of age