Intravenous Fish Oils in the Treatment of Parenteral Nutrition Liver Injury
Open Protocol for the Use of an Intravenous Fat Emulsion Comprised of Fish Oils (Omegaven) in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury
The purpose of this study is to provide intravenous omega-3 fatty acids and monitor
tolerance in subjects with prolonged parenteral nutrition dependence and parenteral
nutrition-associated cholestasis through expanded access.
Therapy with Omegaven will be initiated and maintained at 1 g/kg/day in subjects with
parenteral nutrition-associated cholestasis and prolonged parenteral nutrition dependence
who qualify for expanded access. It will be infused intravenously through either a central
or peripheral catheter in conjunction with parenteral nutrition. If additional non-protein
calories are needed, they will be provided as carbohydrates. No other parenteral form of fat
emulsion will be used during Omegaven therapy unless the subject is not receiving adequate
calories and additional dextrose may not be administered to the subject because of severe
persistent hyperglycemia, respiratory compromise, or other clinical conditions, or unless
the patient develops essential fatty acid deficiency as confirmed by laboratory parameters.
The same standards of care provided to all subjects receiving parenteral nutrition solution
will be followed.
Regular PN monitoring will be accomplished by analyzing clinical and laboratory parameters,
including serum electrolytes, hematological studies, renal function, hepatic function, blood
clotting factors, protein and nutrition status and trace mineral status. An essential fatty
acid profile and lipid panel will be sampled from the subject to monitor the effects of
Blood will be sampled for an essential fatty acid profile and lipid panel before beginning
Omegaven, weekly while the patient is on Omegaven and has a direct (conjugated) bilirubin ≥
2 mg/dL, and then monthly while the patient is on Omegaven and has a direct (conjugated)
bilirubin < 2 mg/dL. Subjects will also be monitored daily for clinical signs and symptoms
of essential fatty acid deficiency, including dermatitis and hair loss.
Dose reduction and titration or discontinuation will occur if there is evidence of
hypertriglyceridemia (serum triglycerides > 200 mg/dL), allergic response, toxicity or
evidence of bleeding that is believed to be caused or worsened by Omegaven. If lipid
intolerance develops, defined as serum triglyceride level > 200 mg/dL, lipids will be
stopped for at least 4 hours and a repeat serum triglyceride level will be obtained. If the
triglycerides continue to remain high a dosage reduction of 25% of the current dose will be
considered. Growth indices include weight, length, and head circumference will also be
monitored. The Omegaven dose may be discontinued if the subject is receiving adequate
enteral nutrition to meet metabolic and growth needs.
Subjects will receive follow-up visits per the customary medical (GI) or surgical follow-up
schedule for a period of 36 months after discontinuation of Omegaven. Follow up visits will
occur at least annually, but may be more frequent based on the subjects' tolerance of and
weight gain on enteral nutrition.
As previously mentioned, Omegaven will be infused in the same manner as conventional fat
emulsions through either a central or peripheral line. The emulsion is isotonic. It is
compatible with parenteral nutrition solutions and may be co-infused via y-site. Source
containers will be changed every 24 hours and unused product discarded. Omegaven may be
infused through a 1.2 micron inline filter.
Cholestasis, Total Parenteral Nutrition-induced Cholestasis
Rush University Medical Center
Rush University Medical Center
Puder M, Valim C, Meisel JA, Le HD, de Meijer VE, Robinson EM, Zhou J, Duggan C, Gura KM. Parenteral fish oil improves outcomes in patients with parenteral nutrition-associated liver injury. Ann Surg. 2009 Sep;250(3):395-402. doi: 10.1097/SLA.0b013e3181b36657.
Gura KM, Lee S, Valim C, Zhou J, Kim S, Modi BP, Arsenault DA, Strijbosch RA, Lopes S, Duggan C, Puder M. Safety and efficacy of a fish-oil-based fat emulsion in the treatment of parenteral nutrition-associated liver disease. Pediatrics. 2008 Mar;121(3):e678-86. doi: 10.1542/peds.2007-2248.