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Published on: March 23, 2018
Triiodothyronine Supplementation in Infants Undergoing Cardiopulmonary Bypass: A Randomized Controlled Trial
Michael A Portman1, April E Slee2, Stephen J Roth3
1Seattle Children's Research Institute and Department of Pediatrics, University of Washington, Seattle, Washington.
Insights
Triiodothyronine (T3) supplementation did not reduce time to extubation in infants after cardiopulmonary bypass (CPB). This thyroid hormone therapy was found to be safe, with no increase in adverse events observed in the study population.
Area of Science:
- Pediatric Critical Care
- Cardiothoracic Surgery
- Pediatric Endocrinology
Background:
- Cardiopulmonary bypass (CPB) significantly lowers thyroid hormone levels in infants.
- Thyroid hormone deficiency may impact recovery after cardiac surgery in neonates and infants.
Purpose of the Study:
- To evaluate the efficacy of intravenous triiodothyronine (T3) supplementation in reducing time to extubation (TTE) in infants following CPB.
- To assess the safety of T3 supplementation in this vulnerable patient population.
Main Methods:
- A multicenter, randomized, placebo-controlled trial involving 220 infants undergoing cardiac surgery with CPB.
- Infants were stratified into two age groups (≤30 days and >30 days to <152 days) and received either intravenous T3 or placebo until extubation or 48 hours.
- Primary endpoint was TTE, with secondary assessments of arrhythmias and other adverse events.
Main Results:
- T3 supplementation did not significantly alter TTE in the entire cohort (HR 1.08, P=0.575).
- No significant effect on TTE was observed in either the younger (HR 0.82, P=0.341) or older (HR 1.38, P=0.095) age subgroups.
- T3 did not significantly impact TTE within the first 48 hours (HR 1.371, P=0.099) and was not associated with increased adverse events.
Conclusions:
- Intravenous T3 supplementation does not improve time to extubation in infants after CPB.
- T3 supplementation is safe in this population, showing no increase in adverse events.
- Variability in surgical risk, though balanced between groups, complicated study analysis.
Abstract:
Cardiopulmonary bypass (CPB) profoundly suppresses circulating thyroid hormone levels in infants. We performed a multicenter randomized placebo controlled trial to determine if triiodothyronine (T3) supplementation improves reduces time to extubation (TTE) in infants after CPB. Infants (n = 220) undergoing cardiac surgery with CPB and stratified into 2 age cohorts: ≤30 days and >30 days to <152 days were randomization to receive either intravenous triiodothyronine or placebo bolus followed by study drug infusion until extubated or at 48 hours, whichever preceded. T3 did not significantly alter the primary endpoint, TTE (hazard ratio for chance of extubation (1.08, 95% CI: 0.82-1.43, P = 0.575) in the entire randomized population with censoring at 21 days. T3 showed no significant effect on TTE (HR 0.82, 95% CI:0.55-1.23, P = 0.341) in the younger subgroup or in the older (HR 1.38, 95% CI:0.95-2.2, P = 0.095). T3 also did not significantly impact TTE during the first 48 hours while T3 levels were maintained (HR 1.371, 95% CI:0.942-1.95, P = 0.099) No significant differences occurred for arrhythmias or other sentinel adverse events in the entire cohort or in the subgroups. This trial showed no significant benefit on TTE in the entire cohort. T3 supplementation appears safe as it did not cause an increase in adverse events. The study implementation and analysis were complicated by marked variability in surgical risk, although risk categories were balanced between treatment groups.
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