At a glance
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Oral Triiodothyronine Normalizes T3 Levels After Surgery For Pediatric Congenital Heart Disease
In Brief
A Phase 2 clinical trial evaluating Oral T3 Low dose, Placebo, and 1 other intervention for Low T3 Syndrome. Completed, enrolled 45 participants across 1 site.
Detailed Summary
Low triiodothyronine (T3) syndrome defines as decrease of T3 levels during critically ill. This decrease of T3 levels was observed after congenital heart surgery using cardiopulmonary bypass. Previous largest study,Triiodothyronine for Infants and Children Undergoing Cardiopulmonary bypass (TRICC) study showed T3 supplementation decreased time to extubation for infants less than 5 months undergoing cardiopulmonary bypass. Intravenous regiment was known effective in maintaining T3 levels during pediatric cardiac surgery. This drug preparation however is not commonly used in many countries due to the relatively high costs and/or the simple lack of availability. The use of oral T3 to treat postoperative low T3 levels in pediatric patients has not been reported so far, although recent adult studies showed benefit in using oral T3 after cardiac surgery. The purpose of this study was to determine if oral T3 supplementation could prevent the decline of serum T3 in children less than 2 years of age undergoing congenital heart surgery using CPB.
Study Details
Timeline
Interventions
Comparison of different dosages of drug. Low dose group oral T3 is 0.5 mcg/kg q24h
Comparison of different dosages of drug. In low dose group, placebo was given alternately with oral T3 every 12h with a total 3 doses for placebo and 3 doses for oral T3
Comparison of different dosages of drugs. Oral T3 high dose is 0.5 mcg/kg q12h