NCT00027417

Study of Triostat in Infants During Heart Surgery

Triostat in Children During CardioPulmonary Bypass (CPB)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 195 (actual)
• Sponsor: Michael Portman · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Defects, Congenital

Interventions

Type	Name	Description
DRUG	Liothyronine sodium/triiodothyronine
PROCEDURE	Cardiopulmonary bypass and cardiac surgery

Timeline

• Start date: 2001-04-01
• Primary completion: 2007-08-01
• Completion: 2007-08-01
• First posted: 2001-12-07
• Last updated: 2013-08-05

Locations

1 site across 1 country: United States