Liothyronine in Children With Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure

Descriptive Information
Brief Title ^†	Liothyronine in Children With Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure
Official Title ^†
Brief Summary	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.
Detailed Description	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 Phase	Phase 1
Study Type ^†	Interventional
Study Design ^†	Allocation: Randomized, Primary Purpose: Treatment
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Tricuspid Atresia Heart Defects, Congenital
Intervention ^†	Drugliothyronine I 131
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status ^†	Drug
Estimated Enrollment ^†	28
Start Date ^†	December 1994
Completion Date	December 1997
Primary Completion Date
Eligibility Criteria ^†	Single ventricle congenital cardiac malformation Must undergo modified Fontan procedure No concurrent medications known to interfere with thyroid metabolism including propranolol and amiodarone No hepatic dysfunction No renal dysfunction No pre-existing thyroid dysfunction
Gender	Both
Ages	N/A - 17 Years
Accepts Healthy Volunteers	No
Contacts ^††	, , , ,
Location Countries ^†
Administrative Information
NCT ID ^†	NCT00004828
Organization ID	199/13357
Secondary IDs ^††	CHSD-585
Responsible Party	,
Study Sponsor ^†	FDA Office of Orphan Products Development
Collaborators ^††	Children's Hospital and Health Center
Investigators ^†	Study Chair: Richard Mainwaring, Children's Hospital and Health Center
Information Provided By	FDA Office of Orphan Products Development
Verification Date	June 1998
First Received Date ^†	February 24, 2000
Last Updated Date	June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.