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.
Bibliographical noteFunding Information:
The TRICC study represents a prospective evaluation of triiodothyronine supplementation for cardiopulmonary bypass in children. Unlike the previous studies, this investigation will be performed at multiple centers with the intent of enrolling a relatively large number of subjects. The intent is to determine if triiodothyronine supplementation alters the length of postoperative mechanical circulatory support. Secondary parameters will also be evaluated. Besides the prospective and controlled multicenter design, the study also differs from many pediatric cardiologic investigations by its funding base. This clinical trial is investigator-initiated and primarily funded through an Orphan Product Development grant program administered by the Food and Drug Administration. The goal of the grant program is to encourage clinical development of products for use in rare diseases or conditions, usually defined as affecting fewer than 200,000 people in the United States. Therefore, this funding mechanism is available for most investigator-initiated clinical and device trials in adults and children with congenital heart disease.