Intravenous Fish Oils in the Treatment of Parenteral Nutrition Liver Injury

• Status: Approved for marketing
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

Details

• Lead Sponsor: Rush University Medical Center

Criteria

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