Document Detail


Triiodothyronine Supplementation in Infants and Children Undergoing Cardiopulmonary Bypass (TRICC): a multicenter placebo-controlled randomized trial: age analysis.
MedLine Citation:
PMID:  20837917     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Triiodothyronine levels decrease in infants and children after cardiopulmonary bypass. We tested the primary hypothesis that triiodothyronine (T3) repletion is safe in this population and produces improvements in postoperative clinical outcome.
METHODS AND RESULTS: The TRICC study was a prospective, multicenter, double-blind, randomized, placebo-controlled trial in children younger than 2 years old undergoing heart surgery with cardiopulmonary bypass. Enrollment was stratified by surgical diagnosis. Time to extubation (TTE) was the primary outcome. Patients received intravenous T3 as Triostat (n=98) or placebo (n=95), and data were analyzed using Cox proportional hazards. Overall, TTE was similar between groups. There were no differences in adverse event rates, including arrhythmia. Prespecified analyses showed a significant interaction between age and treatment (P=0.0012). For patients younger than 5 months, the hazard ratio (chance of extubation) for Triostat was 1.72. (P=0.0216). Placebo median TTE was 98 hours with 95% confidence interval (CI) of 71 to 142 compared to Triostat TTE at 55 hours with CI of 44 to 92. TTE shortening corresponded to a reduction in inotropic agent use and improvement in cardiac function. For children 5 months of age, or older, Triostat produced a significant delay in median TTE: 16 hours (CI, 7-22) for placebo and 20 hours (CI, 16-45) for Triostat and (hazard ratio, 0.60; P=0.0220).
CONCLUSIONS: T3 supplementation is safe. Analyses using age stratification indicate that T3 supplementation provides clinical advantages in patients younger than 5 months and no benefit for those older than 5 months. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00027417.
Authors:
Michael A Portman; April Slee; Aaron K Olson; Gordon Cohen; Tom Karl; Elizabeth Tong; Laura Hastings; Hitendra Patel; Olaf Reinhartz; Antonio R Mott; Richard Mainwaring; Justin Linam; Sara Danzi;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Circulation     Volume:  122     ISSN:  1524-4539     ISO Abbreviation:  Circulation     Publication Date:  2010 Sep 
Date Detail:
Created Date:  2010-09-14     Completed Date:  2010-10-01     Revised Date:  2014-09-24    
Medline Journal Info:
Nlm Unique ID:  0147763     Medline TA:  Circulation     Country:  United States    
Other Details:
Languages:  eng     Pagination:  S224-33     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00027417
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MeSH Terms
Descriptor/Qualifier:
Age Factors
Arrhythmias, Cardiac / chemically induced
Cardiopulmonary Bypass*
Child, Preschool
Double-Blind Method
Female
Heart Defects, Congenital / therapy*
Humans
Infant
Infant, Newborn
Male
Proportional Hazards Models
Prospective Studies
Time Factors
Triiodothyronine / administration & dosage*,  adverse effects
Grant Support
ID/Acronym/Agency:
1ULI RR025014-01/RR/NCRR NIH HHS; R01 FD-R-1971-01/FD/FDA HHS; UL1 RR025014/RR/NCRR NIH HHS; UL1 RR025014-01/RR/NCRR NIH HHS
Chemical
Reg. No./Substance:
06LU7C9H1V/Triiodothyronine
Investigator
Investigator/Affiliation:
L Permut / ; M Lewin / ; A Cesan / ; M B Lee / ; C Fearneyhough / ; K Rodriquez / ; K Gama / ; E Mano / ; T A Tacy / ; A Azakie / ; J Simon / ; G Kung / ; T Donnel / ; R Pignatelli / ; I Klein / ; R Knopp / ; F Kim / ; B Hardy / ; M Cohen / ; H Burkhardt /
Comments/Corrections

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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