Study of Triostat in Infants During Heart Surgery

Michael Portman

Status and phase

Completed

Phase 3

Conditions

Heart Defects, Congenital

Treatments

Procedure: Cardiopulmonary bypass and cardiac surgery

Drug: Liothyronine sodium/triiodothyronine

Study type

Interventional

Funder types

Other

Identifiers

NCT00027417

FD-R-001971-01

FD-R-1971-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

195 patients

Sex

All

Ages

Under 2 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

195 participants in 2 patient groups, including a placebo group

Liothyronine Sodium/Triiodothyronine

Active Comparator group

Description:

bolus administration of Liothyronine Sodium/Triiodothyronine (Triostat) immediately prior to CPB institution and after removal of aortic cross clamp, followed by repeated boluses, will be safe and will result in significant improvements in postoperative and clinical outcome parameters and cardiac contractile function.

Treatment:

Drug: Liothyronine sodium/triiodothyronine

Procedure: Cardiopulmonary bypass and cardiac surgery

Placebo

Placebo Comparator group

Description:

bolus administration of Placebo immediately prior to CPB institution and after removal of aortic cross clamp, followed by repeated boluses

Treatment:

Drug: Liothyronine sodium/triiodothyronine

Procedure: Cardiopulmonary bypass and cardiac surgery