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.
Graphical Abstract
Graphical Abstract
Keywords
Abbreviations:
T3 (Triiodothyronine), CPB (Cardiopulmonary bypass), TTE (Time to Extubation), TRICC (Triiodothyronine during Cardiopulmonary bypass in Infants and Children)To read this article in full you will need to make a payment
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Article info
Publication history
Published online: January 26, 2022
Footnotes
Funding: Funding was provided by the U.S Food and Drug Administration Office of Orphan Product Development by Grant R01 FD004362 to M.A.P.
INSTITUTIONAL REVIEW BOARD FWA00002443, Approval 14798, October 17, 2013.
Parents of subjects provided informed consent for participation in this trial.
ClinicalTrials.gov NCT02320669.
Disclosures: The authors have no financial conflicts to disclose.
Conflicts of interest: The authors have no conflicts of interest to disclose.
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© 2022 Elsevier Inc. All rights reserved.
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Access this article on ScienceDirectLinked Article
- Commentary: The Trials and Tribulations of T3 SupplementationSeminars in Thoracic and Cardiovascular SurgeryVol. 35Issue 1
- PreviewIn this issue of Seminars, Portman and colleagues report the results of a 3-center, randomized, controlled trial (RCT) of triiodothyronine (T3) supplementation in infants <152 days old undergoing cardiac surgery with cardiopulmonary bypass (CPB).1 They randomized 220 infants (103 neonates) and found no difference in their primary endpoint, time to extubation, or any secondary endpoints including vasoactive score, ICU length of stay (LOS), or presence of low cardiac output. This rigorously conducted RCT represents the culmination of years of work by the investigative team seeking to understand the potential benefits of T3 supplementation.
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