Omegaven Treatment of Parenteral Nutrition (PN) Induced Liver Injury
Completed · Not applicable
Conditions studied: Liver Injury
In brief
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.
Key facts
- Study ID
- NCT01089426
- Run by
- Children's Hospital Los Angeles
- People needed
- 90
- Starts
- 2008-09-01
- Expected to finish
- 2019-04-01
- Last updated by the study team
- 2019-05-06
Who can join
Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Childrens Hospital Los Angeles — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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