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Safer Parenteral Nutrition in Pediatric Short Bowel Syndrome to Decrease Liver Damage

Expanded access is currently available for this treatment.
Verified June 2016 by Georgetown University
Information provided by (Responsible Party):
Georgetown University Identifier:
First received: May 22, 2013
Last updated: January 24, 2017
Last verified: June 2016
To provide children dependent on total parenteral nutrition with Omegaven®, a fish oil-based intravenous lipid emulsion that may be less hepatotoxic than conventional, vegetable oil-based intravenous lipid emulsions, and that may therefore reduce the need for liver transplantation.

Condition Intervention
Cholestasis of Parenteral Nutrition
Drug: Omegaven 10%

Study Type: Expanded Access     What is Expanded Access?
Official Title: A Safer Approach to Total Parenteral Nutrition in Pediatric Short Bowel Syndrome Intended to Decrease the Frequency and Severity of Liver Damage

Resource links provided by NLM:

Further study details as provided by Georgetown University:

Intervention Details:
    Drug: Omegaven 10%

    Patients with a sustained TPN requirement due to short bowel syndrome and TPN-associated liver disease that threatens progression to liver failure and death, for which the only available means of prevention at present is timely liver and/or intestinal transplant.

    Omegaven 10%, 1 gram/kg, IV, every 12 hours until transplantation, or stopping TPN


Ages Eligible for Study:   2 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • The targeted population for enrollment is the cohort of patients with TPN-dependent short bowel syndrome, defined as any pediatric patient who, following abdominal surgery, has a residual small bowel length less than 25% of that predicted for gestational age or requires postoperative TPN for more than 42 days because of gastrointestinal intolerance and who has developed TPN-associated liver disease sufficient to pose a significant risk for progression to liver failure based on the following criteria:

    • Total serum bilirubin concentration greater than 3 mg/dL after a total duration of TPN greater than 2 months in the absence of a proven episode of bacteremia within the preceding 3 weeks.


• Platelet count less than 200,000/μL after a total duration of TPN greater than 2 months in the absence of a proven episode of bacteremia within the preceding 3 weeks.


• Serum albumin concentration less than 3.2 mg/dL after a total duration of TPN greater than 2 months in the absence of a proven episode of bacteremia within the preceding 3 weeks.

Patients with coagulopathy due to parenteral nutrition-associated liver disease (INR > 1.2) will be potential candidates for enrollment, because patients with an elevated INR exceeding 2 have demonstrated resolution of coagulopathy after treatment with Omegaven®. Similarly, patients with hyperlipidemia will be potential candidates for enrollment.

Alternatively, patients currently receiving Omegaven that was initiated at another center because of intestinal failure with liver disease that do not need to meet the lab criteria listed above. The subject may continue Omegaven under this protocol at the discretion of the Principle Investigator.

Exclusion Criteria:

Patients with a history of the following will be excluded from enrollment in this protocol:

  • Allergy to fish or egg protein.
  • Liver disease proven or suspected to be caused by a process other than TPN-dependent short bowel syndrome, including but not limited to hepatitis C, hepatitis B, cystic fibrosis, biliary atresia, Alagille syndrome, familial intrahepatic cholestasis, and alpha-1-antitrypsin deficiency.
  • Refusal of third party providers to reimburse hospital for the cost of Omegaven®.
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Please refer to this study by its identifier: NCT01861834

Contact: Stuart S. Kaufman, MD 202-444-0906

United States, District of Columbia
MedStar Georgetown Transplant Institute
Washington, District of Columbia, United States, 20007
Principal Investigator: Stuart Kaufman, MD         
MedStar Georgetown University Hospital
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
  More Information

Responsible Party: Georgetown University Identifier: NCT01861834     History of Changes
Other Study ID Numbers: IND107300
Study First Received: May 22, 2013
Last Updated: January 24, 2017

Keywords provided by Georgetown University:
Total parenteral nutrition
Intestinal Failure
Short Bowel Syndrome
Intestinal failure associated liver disease
Parenteral nutrition associated liver disease

Additional relevant MeSH terms:
Short Bowel Syndrome
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Postoperative Complications
Pathologic Processes processed this record on May 25, 2017