View Clinical Trial (Medical Research Study)
Compassionate Use of Omegaven IV Fat Emulsion
| City: |
|
New Hyde Park |
| State: |
|
New York |
| Zip Code: |
|
11040 |
| Conditions: |
|
Cholestasis - Parenteral Nutrition Associated Liver Disease |
| Purpose: |
|
This is a compassionate use protocol to use intravenous fish oil infusion, Omegaven®, to
infants and children with parenteral nutrition-associated liver disease to enable reversal
of elevated serum liver enzymes and direct bilirubin (cholestasis).
|
| Study Summary: |
|
Intravenous lipids are necessary in PN (parenteral nutrition) dependent patients due to
their high caloric value and essential fatty acid content. However, parenteral fat emulsions
composed of soybean oils (omega 6 fatty acids) have been implicated in predisposing patients
to PN associated liver disease.
It is hypothesized that by administering Omegaven®, comprised of fish oil (omega 3 fatty
acids) in place of conventional soybean fat emulsion, the progression of PN-associated
cholestasis may be prevented or reversed.
|
| Criteria: |
|
Inclusion Criteria:
- Two consecutive direct bilirubin levels of 2 mg/dl or more in a parenteral nutrition
dependent infant or child (unable to meet nutritional needs solely by enteral
nutrition)
- Other causes of liver disease have been excluded. A liver biopsy is not necessary for
treatment.
- The patient must have utilized standard therapies to prevent the progression of the
liver disease including reduction/removal of copper and manganese from daily PN,
trial of enteral feeding if possible, and the use of ursodiol (i.e., Actigall®).
Exclusion Criteria:
- Documented causes of chronic liver disease other than parenteral nutrition associated
liver disease
- Proven severe advanced liver disease including cirrhosis on biopsy, varices, ascites.
- An allergy to any seafood product, egg protein, and/or previous allergy to Omegaven®
- Active coagulopathy characterized by ongoing bleeding or by a requirement for
clotting factor replacement (e.g. fresh frozen plasma or cryoprecipitate) to maintain
homeostasis
- Impaired lipid metabolism or severe hyperlipidemia with or without pancreatitis
- Unstable diabetes mellitus or hyperglycemia
- Stroke, embolism, collapse and shock, recent MI
- Cholestasis due to any reason other than parenteral associated liver disease
- Active new infection at time of initiation of Omegaven®
- Hemodynamic instability
- The patient may not be enrolled in any other clinical trial involving an
investigational agent (unless approved by the designated physicians on the
multidisciplinary team).
|
| NCT ID: |
|
NCT00816348 |
| Primary Contact: |
|
Principal Investigator
Richard J Schanler, MD
Cohen Children's Medical Center of New York at North Shore
Richard J Schanler, MD
Phone: (516) 562-4665
Email: Schanler@nshs.edu
|
| Backup Contact: |
|
Email: Dpotak@nshs.edu
Debra C Potak, RN
Phone: (516) 562-2205
|
| Location Contact: |
|
New Hyde Park, New York 11040
United States
Richard J Schanler, MD
Phone: 516-562-4665
Email: Schanler@nshs.edu
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 18, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|