Liothyronine in Children With Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure
|Brief Title †||Liothyronine in Children With Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure|
|Official Title †|
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.
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 †|
|Intervention †||Drugliothyronine I 131|
|Study Arms / Comparison Groups|
|* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.|
|Recruitment Status †||Drug|
|Estimated Enrollment †||28|
|Start Date †||December 1994|
|Completion Date||December 1997|
|Primary Completion Date|
|Eligibility Criteria †||
|Ages||N/A - 17 Years|
|Accepts Healthy Volunteers||No|
|Location Countries †|
|NCT ID †||NCT00004828|
|Secondary IDs ††||CHSD-585|
|Study Sponsor †||FDA Office of Orphan Products Development|
|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|
†† WHO trial registration data element that is required only if it exists.