TY - JOUR
T1 - The Triiodothyronine for Infants and Children Undergoing Cardiopulmonary Bypass (TRICC) study
T2 - Design and rationale
AU - Portman, Michael A.
AU - Fearneyhough, Collette
AU - Karl, Tom R.
AU - Tong, Elizabeth
AU - Seidel, Kristy
AU - Mott, Antonio
AU - Cohen, Gordon
AU - Tacy, Theresa
AU - Lewin, Mark
AU - Permut, Lester
AU - Schlater, Mary
AU - Azakie, Anthony
PY - 2004/9/1
Y1 - 2004/9/1
N2 - 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. Methods and 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.
AB - 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. Methods and 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.
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U2 - 10.1016/j.ahj.2004.03.029
DO - 10.1016/j.ahj.2004.03.029
M3 - Article
C2 - 15389224
AN - SCOPUS:4644231231
VL - 148
SP - 393
EP - 398
JO - American Heart Journal
JF - American Heart Journal
SN - 0002-8703
IS - 3
ER -