Liver Injury Clinical Trial
Official title:
Research Study of an Intravenous Fat Emulsion Comprised of Fish Oils (Omegaven) in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury
NCT number | NCT01089426 |
Other study ID # | CCI-08-00127 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2008 |
Est. completion date | April 2019 |
Verified date | May 2019 |
Source | Children's Hospital Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | April 2019 |
Est. primary completion date | April 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 21 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Childrens Hospital Los Angeles | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Los Angeles |
United States,
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* Note: There are 30 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of reduction of direct bilirubin | normalization of direct bilirubin: an expected average of approximately 5 months |
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