Study of Triostat in Infants During Heart Surgery

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Michael Portman

Criteria

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.