title: A randomized, double-blind, placebo-controlled pilot trial of triiodothyronine in neonatal heart surgery.
abstract: OBJECTIVE
  This study was undertaken to evaluate the effect of triiodothyronine replacement on the early postoperative course of neonates undergoing aortic arch reconstruction.
  
  
  METHODS
  We performed a randomized, double-blind, placebo-controlled trial of triiodothyronine supplementation in neonates undergoing either a Norwood procedure or two-ventricle repair of interrupted aortic arch and ventricular septal defect. Patients were assigned to receive a continuous infusion of triiodothyronine (0.05 micro/kg/h) or placebo for 72 hours after cardiopulmonary bypass. Primary end points were a composite clinical outcome score and cardiac index at 48 postoperative hours.
  
  
  RESULTS
  We enrolled 42 patients (triiodothyronine n = 22, placebo n = 20). Baseline characteristics were similar in the treatment groups. Study drug was discontinued prematurely because of hypertension (n = 1) and ectopic atrial tachycardia (n = 1), both cases in the triiodothyronine group. Free and total triiodothyronine levels were higher in the triiodothyronine group than in the placebo group at 24, 48, and 72 postoperative hours (P < .001). The median clinical outcome scores were 2.0 (range 0-4) with triiodothyronine and 2.0 (range 0-7) with placebo (P = .046). Compared with those in the placebo group, neonates assigned to triiodothyronine had shorter median time to negative fluid balance (2.0 vs 2.5 days, P = .027). Cardiac index values were 2.11 +/- 0.64 L/min x m2 with triiodothyronine and 2.05 +/- 0.72 L/min x m2 with placebo (P = .81). Heart rate and diastolic blood pressure were not influenced by triiodothyronine supplementation, but systolic blood pressure was higher in the triiodothyronine group (P < .001). No serious adverse events were attributed to triiodothyronine administration.
  
  
  CONCLUSIONS
  Triiodothyronine supplementation was safe and resulted in more rapid achievement of negative fluid balance after aortic arch reconstruction. Cardiac index at 48 hours was not significantly improved.
authors.affiliation: Department of Cardiology, Children's Hospital Boston, Boston, Mass, USA. andrew.mackie@muhc.mcgill.ca
authors.forename: Andrew S
authors.initials: AS
authors.lastname: Mackie
authors.forename: Karen L
authors.initials: KL
authors.lastname: Booth
authors.forename: Jane W
authors.initials: JW
authors.lastname: Newburger
authors.forename: Kimberlee
authors.initials: K
authors.lastname: Gauvreau
authors.forename: Stephen A
authors.initials: SA
authors.lastname: Huang
authors.forename: Peter C
authors.initials: PC
authors.lastname: Laussen
authors.forename: James A
authors.initials: JA
authors.lastname: DiNardo
authors.forename: Pedro J
authors.initials: PJ
authors.lastname: del Nido
authors.forename: John E
authors.initials: JE
authors.lastname: Mayer
authors.forename: Richard A
authors.initials: RA
authors.lastname: Jonas
authors.forename: Ellen
authors.initials: E
authors.lastname: McGrath
authors.forename: Jodi
authors.initials: J
authors.lastname: Elder
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Roth
mesh_terms: D001013:Aorta, Thoracic / Q000002:abnormalities; D002302:Cardiac Output / Q000187:drug effects; D006348:Cardiac Surgical Procedures; D004311:Double-Blind Method; D005260:Female; D006330:Heart Defects, Congenital / Q000601:surgery*; D006345:Heart Septal Defects, Ventricular / Q000601:surgery; D006801:Humans; D007231:Infant, Newborn; D007262:Infusions, Intravenous; D008297:Male; D011182:Postoperative Care; D014284:Triiodothyronine / Q000008:administration & dosage*
chemical_list: D014284:Triiodothyronine