Liothyronine in Children With Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure
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|ClinicalTrials.gov Identifier: NCT00004828|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : March 25, 2015
OBJECTIVES: I. Determine the pharmacokinetics of exogenous liothyronine administered in children undergoing the modified Fontan procedure.
II. Determine the liothyronine supplementation dose that counters the fall in serum liothyronine concentrations and provides the greatest potential myocardial benefit after the modified Fontan procedure.
III. Evaluate the potential toxicity of exogenous liothyronine administered in children undergoing a modified Fontan procedure.
|Condition or disease||Intervention/treatment||Phase|
|Tricuspid Atresia Heart Defects, Congenital||Drug: liothyronine I 131||Phase 1|
PROTOCOL OUTLINE: This is a randomized, placebo controlled, dose escalation study.
Initially, patients are randomized to receive either 1 of 3 different dosages of liothyronine or placebo after undergoing the Fontan procedure. If no unacceptable toxicity is observed in this group, a third dose level of liothyronine is added to the randomization. A total of 7 patients are enrolled at each dose level. All randomized study drugs are administered by continuous infusion over 1 hour after surgery.
Cardiac function is assessed 5 days after surgery.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Study Start Date :||December 1994|
|Estimated Study Completion Date :||December 1997|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004828
|Study Chair:||Richard Mainwaring||Children's Hospital and Health Center|