2011 - ISBTS 2011 Symposium
Plenary Session I: Disappearing PNLD? + Oral Communications 1
3.102 - Prospective, case-control trial of 24 weeks of intravenous fish oil in children with intestinal failure associated liver disease
Presenter: Kara, Calkins, Los Angeles, United States
Authors: Kara Calkins1, Stephen Shew2, James Dunn2, Douglas Farmer2, Robert Venick1,2
Prospective, case-control trial of 24 weeks of intravenous fish oil in children with intestinal failure associated liver disease
Kara Calkins1, Stephen Shew2, James Dunn2, Douglas Farmer2, Robert Venick1,2
1Department of Pediatrics, UCLA , Los Angeles, CA, United States; 2Department of Surgery, UCLA, Los Angeles, CA, United States
Background: Intestinal Failure Associated Liver Disease (IFALD) is a major cause of mortality among children with intestinal failure (IF). Cohort studies have reported that IV fish oil (FO) reverses cholestasis and prevents death and transplant.
Objective: To determine the efficacy of a finite FO course.
Methods: FDA and IRB approval was obtained. Inclusion criteria: direct bilirubin (DB) ≥ 2 mg/dL, > 2 weeks of age < 18 years, acquired/congenital GI disorder, and > 60% of parenteral nutrition (PN) calories. IV soybean oil (SO) was replaced with FO (Omegaven™), 1 gm/kg/d IV for 24 weeks or until death or transplant. For comparison, historical SO controls who fulfilled inclusion criteria were matched one-to-one. Baseline characteristics were compared using Chi-square and t-tests. Liver function tests and safety markers were compared over time using repeated measures of ANOVA.
Results: 8 FO subjects (median enrollment age: 68 days) were compared to 8 SO. There were no significant differences in baseline demographics, GI diagnosis/anatomy, PN calories, glucose and protein, transaminases, alkaline phosphatase, platelet count, triglycerides and albumin. At enrollment FO had more septic episodes (1.6±0.9 vs 0.4±0.7, p<0.05), higher DB (6.5±3.4 vs 3.7±1.7 mg/dL, p<0.05), received more enteral calories (23±13 vs 3±4%, p<0.005) and less SO (1.3±0.8 vs 2.7±0.5 g/kg/day, p<0.005). At the study endpoint, significant improvements were observed for FO vs SO in DB (0.2±0.1 vs 11.2±5.8 mg/dL, p<0.01), AST (90±47 vs 268±130 U/L, p<0.05) and platelet count (265±166 vs 108±71, p<0.05); no differences were seen in ALT, alkaline phosphatase, albumin, or transplant-free survival. Median time to reversal of cholestasis (DB < 2 mg/dL) in FO was 14±3.2 weeks. No adverse events were observed.
Conclusions: This unique prospective, case-control study demonstrates that short-term administration of FO reverses cholestasis. Follow-up is required to corroborate the long-term sustainability of this effect. This study supports the existing clinical practice that enteral nutrition and low dose IV fat appear to ameliorate IFALD.
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