title: Oral Triiodothyronine for Infants and Children Undergoing Cardiopulmonary Bypass.
abstract: BACKGROUND
  This study evaluated the efficacy and safety of oral triiodothyronine (T3; Tetronine, Dalim BioTech, Korea) for infants and children undergoing cardiopulmonary bypass in an Indonesian population.
  
  
  METHODS
  We performed a single-center, randomized, double-blind, and placebo-controlled trial in children aged 3 years and younger undergoing congenital heart disease operations with cardiopulmonary bypass. We administered oral T3 (1 μg/kg per body weight/dose) or placebo (saccharum lactis) by nasogastric tube every 6 hours for 60 hours after induction of anesthesia. The primary end point, time to extubation, was compared with Cox regression.
  
  
  RESULTS
  The modified intention-to-treat group included 101 placebo and 104 treated patients. The stratified log-rank test did not show a significant treatment difference (p = 0.061) for time to extubation, but after adjustment for age, the nutritional Z score, and Aristotle surgical complexity, the hazard ratio was 1.33 (95% confidence interval, 1.00 to 1.76; p = 0.049). The effect of T3 was stronger in the strata aged 5 months and younger (hazard ratio, 1.86; 95% confidence interval 1.02 to 3.39; p = 0.043). Median intubation time was 47.3 hours for the placebo and 32.1 hours for the T3 group in aged 5 months and younger. Adverse events rates, including arrhythmia, were similar between groups, although sepsis was more frequent with placebo.
  
  
  CONCLUSIONS
  Oral T3 supplementation may shorten time to extubation in children undergoing congenital heart disease operations, particularly infants aged 5 months or younger. Administration is relatively safe, simple and inexpensive.
authors.affiliation: Pediatric Cardiac Intensive Care and Anesthesiology Division, National Cardiovascular Center Harapan Kita, Jakarta, Indonesia. Electronic address: eva.marwali@pjnhk.go.id.
authors.forename: Eva M
authors.initials: EM
authors.lastname: Marwali
authors.affiliation: Pediatric Cardiac Intensive Care and Anesthesiology Division, National Cardiovascular Center Harapan Kita, Jakarta, Indonesia.
authors.forename: Cindy E
authors.initials: CE
authors.lastname: Boom
authors.affiliation: Pediatric Cardiac Intensive Care and Anesthesiology Division, National Cardiovascular Center Harapan Kita, Jakarta, Indonesia.
authors.forename: Novik
authors.initials: N
authors.lastname: Budiwardhana
authors.affiliation: Pediatric Cardiac Surgery Division, National Cardiovascular Center Harapan Kita, Jakarta, Indonesia.
authors.forename: Dicky
authors.initials: D
authors.lastname: Fakhri
authors.affiliation: Pediatric Cardiology and Congenital Heart Disease Division, National Cardiovascular Center Harapan Kita and Department of Cardiology and Vascular Medicine, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.
authors.forename: Poppy S
authors.initials: PS
authors.lastname: Roebiono
authors.affiliation: Pediatric Cardiology and Congenital Heart Disease Division, National Cardiovascular Center Harapan Kita and Department of Cardiology and Vascular Medicine, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.
authors.forename: Anwar
authors.initials: A
authors.lastname: Santoso
authors.affiliation: Center for Clinical Epidemiology and Evidence Based Medicine, Cipto Mangunkusumo Hospital, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.
authors.forename: Sudigdo
authors.initials: S
authors.lastname: Sastroasmoro
authors.affiliation: Axio Research, Seattle, Washington.
authors.forename: April
authors.initials: A
authors.lastname: Slee
authors.affiliation: Seattle Children's Hospital and Research Institute, and University of Washington, Seattle, Washington.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Portman
mesh_terms: D000284:Administration, Oral; D002315:Cardiopulmonary Bypass; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006330:Heart Defects, Congenital / Q000601:surgery*; D006801:Humans; D007223:Infant; D008297:Male; D011183:Postoperative Complications / Q000517:prevention & control*; D012189:Retrospective Studies; D016896:Treatment Outcome; D014284:Triiodothyronine / Q000008:administration & dosage*
chemical_list: D014284:Triiodothyronine