Abstract | OBJECTIVE: SUMMARY AND BACKGROUND DATA: METHODS: We performed an open-labeled trial of a fish oil-based ILE in 42 infants with SBS who developed cholestasis (serum direct bilirubin >2 mg/dL) while receiving soybean oil-based ILE. Safety and efficacy outcomes were compared with those from a contemporary cohort of 49 infants with SBS and cholestasis whose PN course included soybean ILE only. The primary efficacy end-point was time to reversal of cholestasis (direct bilirubin <=2 mg/dL). RESULTS: Three deaths and 1 liver transplantation occurred in the fish oil cohort, compared with 12 deaths and 6 transplants in the soybean oil cohort (P = 0.005). Among survivors not transplanted during PN, cholestasis reversed while receiving PN in 19 of 38 patients in the fish oil cohort versus 2 of 36 patients in the soybean oil cohort. Based on Cox models, subjects receiving fish oil-based ILE experienced reversal of cholestasis 6 times faster (95% CI: 2.0-37.3) than those receiving soybean oil-based ILE. The provision of fish oil-based ILE was not associated with hypertriglyceridemia, coagulopathy, or essential fatty acid deficiency. Moreover, hypertriglyceridemic events and abnormal international normalized ratio levels were more common among controls. CONCLUSIONS:
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Authors | Mark Puder, Clarissa Valim, Jonathan A Meisel, Hau D Le, Vincent E de Meijer, Elizabeth M Robinson, Jing Zhou, Christopher Duggan, Kathleen M Gura |
Journal | Annals of surgery
(Ann Surg)
Vol. 250
Issue 3
Pg. 395-402
(Sep 2009)
ISSN: 1528-1140 [Electronic] United States |
PMID | 19661785
(Publication Type: Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
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Chemical References |
- Fat Emulsions, Intravenous
- Fish Oils
- Soybean Oil
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Topics |
- Cholestasis
(etiology, therapy)
- Data Interpretation, Statistical
- Fat Emulsions, Intravenous
(adverse effects, therapeutic use)
- Female
- Fish Oils
(adverse effects, therapeutic use)
- Humans
- Infant
- Liver Function Tests
- Liver Transplantation
(statistics & numerical data)
- Male
- Parenteral Nutrition
(adverse effects, methods)
- Prospective Studies
- Short Bowel Syndrome
(complications, therapy)
- Soybean Oil
(adverse effects)
- Survival Rate
- Treatment Outcome
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