Study of Triostat in Infants During Heart Surgery

Sponsor

Michael Portman (Other)

Overall Status

Completed

CT.gov ID

NCT00027417

Collaborator

(none)

195

Enrollment

Location

Arms

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Defects, Congenital	Drug: Liothyronine sodium/triiodothyronine Procedure: Cardiopulmonary bypass and cardiac surgery	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

195 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Triostat in Children During CardioPulmonary Bypass (CPB)

Study Start Date :

Apr 1, 2001

Actual Primary Completion Date :

Aug 1, 2007

Actual Study Completion Date :

Aug 1, 2007

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Liothyronine Sodium/Triiodothyronine

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

Procedure: Cardiopulmonary bypass and cardiac surgery

Placebo Comparator: Placebo

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

Drug: Liothyronine sodium/triiodothyronine

Procedure: Cardiopulmonary bypass and cardiac surgery

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 2 Years

Sexes Eligible for Study:

All

Accepts 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