Intravenous Fish Oils in the Treatment of Parenteral Nutrition Liver Injury
APPROVED_FOR_MARKETING
Conditions studied: Cholestasis, Total Parenteral Nutrition-induced Cholestasis
In brief
The purpose of this study is to provide intravenous omega-3 fatty acids and monitor tolerance in subjects with prolonged parenteral nutrition dependence and parenteral nutrition-associated cholestasis through expanded access.
Key facts
- Study ID
- NCT02780193
- Run by
- Rush University Medical Center
- Last updated by the study team
- 2019-04-08
Who can join
Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients from birth to 18 years of age who:
- are receiving PN,
- are predicted to receive at least another 30 days of PN, and
- have liver disease with at least a serum direct (conjugated) bilirubin ≥ 2 mg/dL
- Patients from birth to 18 years of age who have a soybean allergy (per parental report) and require parenteral fat
- Patients with significant liver disease due to parenteral nutrition despite utilization of all appropriate conventional therapies.
- Signed patient/parent informed consent
- Hospitalized due to medical or surgical condition prior to Omegaven initiation
You may not qualify if…
- Those who do not fulfill the inclusion criteria
- Those who choose not to consent to the study
- Those in whom 3rd party funding is not secured to support this investigational treatment
- Known fish or egg protein allergy (per parental report)
- All other causes of liver disease (cystic fibrosis, biliary atresia, and alpha 1 anti- trypsin deficiency)
- Severe hemorrhagic disorders (platelet count below 50000)
- Collapse and shock
- Embolism
- Undefined coma status
- Impaired lipid metabolism (serum triglycerides > 200 mg/dL on 1 g/kg/day intralipid)
- Unstable diabetes mellitus
- Stroke
- Recent cardiac infarction
Where it is running
- Rush University Medical Center — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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