Omegaven® in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Other |
| Healthy: | No |
| Age Range: | Any - 18 |
| Updated: | 4/2/2016 |
| Start Date: | July 2010 |
| End Date: | July 2015 |
| Contact: | Ricardo A. Caicedo, MD |
| Email: | ricardo.caicedo@carolinashealthcare.org |
| Phone: | 704-381-8880 |
Use of a Fish Oil-Based Intravenous Lipid Emulsion (Omegaven®) in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury
The purpose of this study is to determine whether the omega-3 fatty acid emulsion
(Omegaven®), when used in place of the conventional soy-based fat emulsion (Intralipid), is
effective in treating parenteral nutrition associated liver disease (PNALD) in children.
The study hypothesis is that Omegaven® can be safely provided to children who are dependent
on parenteral nutrition and have PNALD, and can reverse or prevent progression of PNALD
until the child can take adequate nutrition by mouth.
(Omegaven®), when used in place of the conventional soy-based fat emulsion (Intralipid), is
effective in treating parenteral nutrition associated liver disease (PNALD) in children.
The study hypothesis is that Omegaven® can be safely provided to children who are dependent
on parenteral nutrition and have PNALD, and can reverse or prevent progression of PNALD
until the child can take adequate nutrition by mouth.
Rationale for Omegaven® Treatment
Unlike conventional intravenous fat emulsions, Omegaven® is comprised solely of fish oils
containing primarily omega-3 fatty acids. Animal studies have shown that IV lipid emulsions
such as fish oil that are high in eicosapentaenic and docosahexaenoic acid reduce impairment
of bile flow as seen in cholestasis caused by conventional fat emulsions(1,2). By
administering Omegaven® in place of conventional phytosterol/soybean fat emulsions, the
cholestasis may be reversed and patients will be able to be maintained on adequate PN until
they are able to ingest adequate nutrition enterally.
References
1. Chen W. Effects of fat emulsions with different fatty acid composition on plasma and
hepatic lipids in rats receiving total parenteral nutrition. Clinical Nutrition
1996;15:24.
2. Yeh S. Effects of fish oil and safflower oil emulsions on diet-induced hepatic
steatosis in rats receiving total parenteral nutrition. Clinical Nutrition 1996;15:80.
Unlike conventional intravenous fat emulsions, Omegaven® is comprised solely of fish oils
containing primarily omega-3 fatty acids. Animal studies have shown that IV lipid emulsions
such as fish oil that are high in eicosapentaenic and docosahexaenoic acid reduce impairment
of bile flow as seen in cholestasis caused by conventional fat emulsions(1,2). By
administering Omegaven® in place of conventional phytosterol/soybean fat emulsions, the
cholestasis may be reversed and patients will be able to be maintained on adequate PN until
they are able to ingest adequate nutrition enterally.
References
1. Chen W. Effects of fat emulsions with different fatty acid composition on plasma and
hepatic lipids in rats receiving total parenteral nutrition. Clinical Nutrition
1996;15:24.
2. Yeh S. Effects of fish oil and safflower oil emulsions on diet-induced hepatic
steatosis in rats receiving total parenteral nutrition. Clinical Nutrition 1996;15:80.
Inclusion Criteria:
- Children 0-18 years of age
- Patients will be PN-dependent and expected to continue PN for at least 30 days
- Patients considered eligible for study participation must have PN-associated liver
diseases . Other causes of liver disease (i.e., biliary atresia, galactosemia,
alpha-1 antitrypsin deficiency) will be excluded. A liver biopsy is not necessary for
treatment
- Direct bilirubin > 2.0 mg/dl
- Signed patient informed consent
- Signed patient assent where applicable.
Exclusion Criteria:
- Pregnancy
- Other causes of chronic liver disease (cystic fibrosis, biliary atresia, alpha-1
antitrypsin deficiency)
- Signs of advanced liver disease including cirrhosis on biopsy, varices, ascites
- The patient is allergic to eggs/shellfish
- The patient has a severe hemorrhagic disorder
- The patient is enrolled in any other clinical trial involving an investigational
agent (unless approved by the designated physicians on the multidisciplinary team)
- The parent or guardian or child unwilling to provide consent or assent.
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