Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027417
Status:
COMPLETED
Last Update Posted:
2013-08-05
First Post:
2001-12-05
Brief Title:
Study of Triostat in Infants During Heart Surgery
Sponsor:
Michael Portman
Organization:
Seattle Childrens Hospital
Study Overview
Official Title:
Triostat in Children During CardioPulmonary Bypass CPB
Status:
COMPLETED
Status Verified Date:
2013-08
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:
This is a study to determine the safety and efficacy of liothyronine sodiumtriiodothyronine Triostat a synthetic thyroid hormone when given to infants with congenital heart disease during cardiopulmonary bypass surgery
Detailed Description:
Patients will be randomized to receive study drug or placebo and randomization will occur stratified to each diagnostic category All patients undergo preoperative echocardiograms to provide preoperative cardiac function data The study drug or placebo will be provided in the operating room as an iv bolus just prior to cardiopulmonary bypass and as a bolus delivered on release of the aortic cross-clamp This will be followed by iv for 12 hours Operative data will be collected including CPB time aortic cross-clamp time length and degree of hypothermia These data will be extracted from the anesthesia record
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FD-R-001971-01 | None | None | None |