Cholestasis
Conditions
Keywords
short bowel syndrome, parenteral nutrition associated liver disease, pediatric
Brief summary
Use of a fish oil emulsion to decrease liver disease due to long term intravenous nutrition.
Detailed description
Unlike conventional intravenous fat emulsions, Omegaven™ is comprised solely of fish oils containing primarily omega-3 fatty acids. Animal studies have shown that IV fat emulsions such as fish oil that are high in eicosapentaenic and docosahexaenoic acids reduce impairment of bile flow as seen in cholestasis caused by conventional fat emulsions. It is thought that by administering Omegaven™ in place of conventional phytosterol/soybean fat emulsions, cholestasis may be prevented or reversed, and patients will be able to be maintained on adequate PN for growth until they are able to ingest adequate nutrition enterally. Ongoing studies are addressing safety and efficacy of Omegaven™ in the pediatric population. In this trial, infants and children with parenteral nutrition associated liver disease will receive Omegaven™ as compassionate use to potentially prevent progression of disease. Safety and efficacy are monitored.
Interventions
DRUGOmega-3 fish oil lipid emulsion
daily intravenous administration of Omegaven fish oil emulsion
Sponsors
Kapiolani Medical Center For Women & Children
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* direct bilirubin \> 2 mg/dl x2 consecutive * parenteral nutrition dependent, expected to continue for at least another 30 days from the first day * patient must have utilized standard therapies to prevent the progression of liver disease
Exclusion criteria
* other primary cause of liver disease not parenteral nutrition-associated * weight \<3 kg * infant or child enrolled in other clinical trial involving an investigational agent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| improving cholestasis | One month, 2 months, 3 months after starting omegaven and 1 month after completing treatment | decline in serum direct bilirubin levels below 2 cm on 2 serial measures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| improving liver function tests | 1 year | includes ALT, AST, GGT, and triglycerides |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLynn M Iwamoto, MD
Kapiolani Medical Center For Women & Children
Outcome results
None listed