Intravenous Fish Oils in the Treatment of Parenteral Nutrition Liver Injury (NCT02780193) | Clinical Trial Compass
APPROVED_FOR_MARKETINGNot Applicable
Intravenous Fish Oils in the Treatment of Parenteral Nutrition Liver Injury
United States
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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
Exclusion Criteria:
* 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