Study of Triostat in Infants During Heart Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Triostat in Children During CardioPulmonary Bypass (CPB)

Conditions
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Heart Defects, Congenital

Intervention / Treatment
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* Drug: Liothyronine sodium/triiodothyronine
* Procedure: Cardiopulmonary bypass and cardiac surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Liothyronine Sodium/Triiodothyronine<br>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. | Drug: Liothyronine sodium/triiodothyronine<br> <br> Procedure: Cardiopulmonary bypass and cardiac surgery<br> <br> |
| Placebo Comparator: Placebo<br>bolus administration of Placebo immediately prior to CPB institution and after removal of aortic cross clamp, followed by repeated boluses | Drug: Liothyronine sodium/triiodothyronine<br> <br> Procedure: Cardiopulmonary bypass and cardiac surgery<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of mechanical ventilation after cardiopulmonary bypass. | Reducing the length of ventilatory support minimizes other postoperative complications, which can contribute to morbidity. | 0 to 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess other parameters | 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. | 0 to 72 hrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congenital heart defects, Hypoplastic left heart syndrome, Complete atrioventricular canal defect, Triostat, Cardiac surgery