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.

Condition	Treatment or Intervention
Heart Defects, Congenital	Drug: Liothyronine sodium/triiodothyronine  Procedure: Cardiopulmonary bypass and cardiac surgery

Further Study Details: 

Expected Total Enrollment:  225

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.

Ages Eligible for Study:  up to  2 Years,  Genders Eligible for Study:  Both

Criteria

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.

Washington
      Children's Hospital and Regional Medical Center, Seattle,  Washington,  98105,  United States; Recruiting

Study ID Numbers:  FD-R-1971-01; FD-R-001971-01
Record last reviewed:  October 2001
Last Updated:  October 13, 2004
Record first received:  December 5, 2001
ClinicalTrials.gov Identifier:  NCT00027417
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08