Research

Omegaven® in the Treatment of TPN-Related Cholestasis

Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Associated Hepatic Injury

Protocol Description

This multicenter study provides an alternative nutritional source for critically ill patients suffering from severe liver disease associated with total parenteral nutrition (TPN). Parenteral nutrition (PN) is a nutritional solution given intravenously to patients unable to tolerate adequate oral feedings. Although PN solutions are necessary and life-sustaining, their use can sometimes result in cholestasis, for which there is no effective treatment. Patients enrolled in the study will be provided with Omegaven®, an intravenous fat emulsion made from omega-3 fish oils, rather than the soybean oils used in standard fat emulsions.

Eligibility Criteria

As a compassionate use protocol, this study enrolls only critically ill patients who are at least 2 months old, who have life-threatening PN-associated cholestasis and who have failed all standard therapies to prevent the progression of their liver disease. All other causes of cholestasis must be ruled out and all subjects must be under the care of the Intestinal Care and Rehabilitation Center at Children’s Hospital of Pittsburgh of UPMC.
Boys: 2 months and older
Girls: 2 months and older

Requirements
Therapy with Omegaven® will be provided by continuous infusion through either a central or peripheral catheter in conjunction with PN until it is no longer required. Patients will be followed through Children’s Intestinal Care and Rehabilitation Clinic (ICARE).
Visits: Requires hospitalization upon initiation
Duration: Determined by the study doctors based on individual patient

Status: Open for Enrollment

Additional Resources
ICARE