Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004828
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2000-02-24
Brief Title:
Liothyronine in Children With Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure
Sponsor:
FDA Office of Orphan Products Development
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1998-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CHSD-FDR001195 | None | None | None |
| CHSD-585 | None | None | None |