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.

Official Title

Triostat in Children during CPB

Conditions

– Heart Defects, Congenital

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study

Further Details

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 Start

Eligibility & Criteria

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.

Total Enrolment

225

Contact Details

[1] Children’s Hospital and Regional Medical Center, Seattle, Washington[2] FDA Office of Orphan Products Development