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The Triiodothyronine for Infants and Children Undergoing Cardiopulmonary Bypass (TRICC) study: design and rationale
Michael A Portman1, Collette Fearneyhough, Tom R Karl
1Division of Cardiology, Department of Pediatrics, Children's Hospital and Regional Medical Center, Seattle, Wash 98105, USA. Michael.Portman@seattlechildrens.org
Insights
The Triiodothyronine for Infants and Children Undergoing Cardiopulmonary Bypass (TRICC) study investigates triiodothyronine supplementation in young children after heart surgery. This trial aims to determine if triiodothyronine improves outcomes by reducing mechanical ventilation duration.
Area of Science:
- Pediatric Cardiology
- Endocrinology
- Cardiothoracic Surgery
Background:
- Cardiopulmonary bypass (CPB) in infants and children causes significant thyroid hormone depression, potentially increasing postoperative complications.
- Previous studies on triiodothyronine supplementation post-CPB in children had limited sample sizes and heterogeneity, hindering definitive conclusions.
- A robust, double-blind, randomized, placebo-controlled trial is essential to establish the safety and efficacy of triiodothyronine in infants.
Purpose of the Study:
- To ascertain the safety and efficacy of triiodothyronine supplementation in infants and children under two years old undergoing CPB for congenital heart disease.
- To evaluate the impact of triiodothyronine on key clinical outcomes, including duration of mechanical ventilation.
- To assess secondary clinical and hemodynamic parameters influenced by triiodothyronine therapy.
Main Methods:
- The Triiodothyronine for Infants and Children Undergoing Cardiopulmonary Bypass (TRICC) study is a multicenter, randomized clinical trial.
- Approximately 200 pediatric patients under two years of age will be enrolled.
- Patients will be randomly assigned to receive either triiodothyronine or a placebo, with stratification based on preoperative diagnosis.
Main Results:
- The study is designed to provide critical data on the primary outcome: duration of mechanical ventilation post-CPB.
- Secondary outcomes will include various clinical and hemodynamic measures to comprehensively assess treatment effects.
- Patient assignment is managed through a stratified block randomization process to ensure balanced groups.
Conclusions:
- The TRICC study is expected to yield significant data on the safety and efficacy of triiodothyronine supplementation in a specific pediatric population.
- Findings will inform clinical practice regarding thyroid hormone management in infants and children following cardiopulmonary bypass for congenital heart defects.
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.
