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Study of Triostat in Infants during Heart Surgery



Study of Triostat in Infants during Heart Surgery

For Condition: Heart Defects, Congenital
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Minimum Age/Maximum Age: /2 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 225

Location and Contact Information:

Children's Hospital and Regional Medical Center *Recruiting*
Seattle,  Washington,  98105
United States
Recruiting Kendall  Magnuson 206-528-5181


Additional Information:
Study ID Numbers:  FD-R-1971-01;  FD-R-001971-01
Study Start Date: April 2001
Record last reviewed: October 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027417

Other Heart Defects, Congenital Studies:
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2. Liothyronine in Children with Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure

3. Study of Triostat in Infants during Heart Surgery

4. Body Water Content in Cyanotic Congenital Heart Disease

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