Study of Triostat in Infants During Heart Surgery - Tabular View

Tracking Information
First Received Date ^ICMJE	December 5, 2001
Last Updated Date	June 23, 2005
Start Date ^ICMJE	April 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00027417 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of Triostat in Infants During Heart Surgery
Official Title ^ICMJE	Triostat in Children During CPB
Brief Summary	This is a study to determine the safety and efficacy of liothyronine sodium/triiodothyronine (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 Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Condition ^ICMJE	Heart Defects, Congenital
Intervention ^ICMJE	Drug: Liothyronine sodium/triiodothyronine Procedure: Cardiopulmonary bypass and cardiac surgery
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 ^ICMJE	Recruiting
Enrollment ^ICMJE	225
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion criteria: Diagnosis of one of the following: Ventricular septal defect (VSD) Infant coarctation of the aorta Transposition of the great arteries Tetralogy of Fallot Complete atrioventricular canal defect Hypoplastic left heart, including patients who undergo a Norwood type procedure for aortic or mitral atresia Patient must be scheduled for surgery. Exclusion criteria: Certain additional defects and/or requirement for additional surgery.
Gender	Both
Ages	up to 2 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00027417
Responsible Party
Study ID Numbers ^ICMJE	FD-R-1971-01, FD-R-001971-01
Study Sponsor ^ICMJE	FDA Office of Orphan Products Development
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	FDA Office of Orphan Products Development
Verification Date	October 2001
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP