Heart Defects, Congenital
Conditions
Keywords
Congenital heart defects, Hypoplastic left heart syndrome, Complete atrioventricular canal defect, Triostat, Cardiac surgery
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.
Interventions
DRUGLiothyronine sodium/triiodothyronine
PROCEDURECardiopulmonary bypass and cardiac surgery
Sponsors
Michael Portman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| duration of mechanical ventilation after cardiopulmonary bypass. | 0 to 72 hours | Reducing the length of ventilatory support minimizes other postoperative complications, which can contribute to morbidity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess other parameters | 0 to 72 hrs | * Need for mechanic circulatory support, fluid balance (intake and output); urine output * Echocardiographic measures to include end-systolic wall stress/fractional shortening ratio * Myocardial performance index (Doppler derived), cardiac index (Doppler derived) * Heart rate, blood pressure and central venous pressure * Free and total T3 levels * Others: All medications including inotropic agents will be recorded with respect to time initiated, terminated, and dosage will be recorded for exploratory analyses. |
Countries
United States
Outcome results
None listed