title: The Triiodothyronine for Infants and Children Undergoing Cardiopulmonary Bypass (TRICC) study: design and rationale.
abstract: BACKGROUND
  Cardiopulmonary bypass induces marked and persistent depression of circulating thyroid hormones in infants and children, possibly contributing to postoperative morbidity. Clinical studies have evaluated parenteral triiodothyronine supplementation after cardiopulmonary bypass in children. However, these investigations had relatively small subject numbers as well as age and diagnosis heterogeneity, thereby limiting ability to determine clinical effect. A double-blind, randomized, placebo-controlled trial is needed to define clinical safety and efficacy of triiodothyronine supplementation in infants.
  
  
  RESULTS
  The Triiodothyronine for Infants and Children Undergoing Cardiopulmonary Bypass (TRICC) study is a multicenter, randomized, clinical trial designed to determine safety and efficacy of triiodothyronine supplementation in children <2 years of age undergoing surgical procedures for congenital heart disease. Duration of mechanical ventilation after completion of cardiopulmonary bypass is the primary clinical outcome parameter with multiple secondary clinical and hemodynamic parameters. Nearly 200 patients will be randomly assigned to receive either triiodothyronine or placebo. Patient assignment will be performed using a stratified block randomization according to specific preoperative diagnosis.
  
  
  CONCLUSIONS
  The TRICC study will provide important data regarding the efficacy and safety of triiodothyronine in this age-specific population undergoing surgery for congenital heart disease.
authors.affiliation: Division of Cardiology, Department of Pediatrics, Children's Hospital and Regional Medical Center, Seattle, Wash 98105, USA. Michael.Portman@seattlechildrens.org
authors.forename: Michael A
authors.initials: MA
authors.lastname: Portman
authors.forename: Collette
authors.initials: C
authors.lastname: Fearneyhough
authors.forename: Tom R
authors.initials: TR
authors.lastname: Karl
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Tong
authors.forename: Kristy
authors.initials: K
authors.lastname: Seidel
authors.forename: Antonio
authors.initials: A
authors.lastname: Mott
authors.forename: Gordon
authors.initials: G
authors.lastname: Cohen
authors.forename: Theresa
authors.initials: T
authors.lastname: Tacy
authors.forename: Mark
authors.initials: M
authors.lastname: Lewin
authors.forename: Lester
authors.initials: L
authors.lastname: Permut
authors.forename: Mary
authors.initials: M
authors.lastname: Schlater
authors.forename: Anthony
authors.initials: A
authors.lastname: Azakie
mesh_terms: D002315:Cardiopulmonary Bypass; D004311:Double-Blind Method; D005260:Female; D006330:Heart Defects, Congenital / Q000601:surgery*; D006801:Humans; D007223:Infant; D008297:Male; D018401:Sample Size; D014284:Triiodothyronine / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D014284:Triiodothyronine