Study of Triostat in Infants During Heart Surgery

Phase 3

Completed

• Conditions: Heart Defects, Congenital
• Interventions: Drug: Liothyronine sodium/triiodothyronine; Procedure: Cardiopulmonary bypass and cardiac surgery

• Registration Number: NCT00027417
• Lead Sponsor: Michael Portman

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.

Study Timeline

• Study Start: 2001-04
• Study First Submitted: 2001-12-05
• Study First Submitted QC: 2001-12-06
• Study First Posted: 2001-12-07
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-01
• Last Update Posted: 2013-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 195

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liothyronine Sodium/Triiodothyronine	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.
Liothyronine Sodium/Triiodothyronine	Cardiopulmonary bypass and cardiac surgery	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.
Placebo	Liothyronine sodium/triiodothyronine	bolus administration of Placebo immediately prior to CPB institution and after removal of aortic cross clamp, followed by repeated boluses
Placebo	Cardiopulmonary bypass and cardiac surgery	bolus administration of Placebo immediately prior to CPB institution and after removal of aortic cross clamp, followed by repeated boluses

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Children's Hospital and Regional Medical Center; 🇺🇸 Seattle, Washington, United States