Heart Defects, Congenital Clinical Trial
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.
;
Allocation: Randomized, Primary Purpose: Treatment
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