Study of Triostat in Infants During Heart Surgery
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.
Heart Defects, Congenital
Drug: Liothyronine sodium/triiodothyronine
Procedure: Cardiopulmonary bypass and cardiac surgery
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
|Official Title:||Triostat in Children During CPB|
|Study Start Date:||April 2001|
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.
|United States, Washington|
|Children's Hospital and Regional Medical Center|
|Seattle, Washington, United States, 98105|