Study of Triostat in Infants During Heart Surgery

This study is currently recruiting participants.

Verified by FDA Office of Orphan Products Development, October 2001

First Received: December 5, 2001 Last Updated: June 23, 2005 History of Changes

Sponsor:	FDA Office of Orphan Products Development
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00027417

Purpose

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	Intervention
Heart Defects, Congenital	Drug: Liothyronine sodium/triiodothyronine Procedure: Cardiopulmonary bypass and cardiac surgery

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Official Title:	Triostat in Children During CPB

Resource links provided by NLM:

MedlinePlus related topics: Congenital Heart Defects Heart Surgery Surgery

Drug Information available for: Liothyronine sodium Triiodothyronine

U.S. FDA Resources

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	225
Study Start Date:	April 2001

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.

Eligibility

Ages Eligible for Study:	up to 2 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00027417

Locations

United States, Washington
Children's Hospital and Regional Medical Center	Recruiting
Seattle, Washington, United States, 98105
Contact: Kendall Magnuson 206-528-5181 resadmin@chmc.org
Principal Investigator: Michael A. Portman, M.D.

Sponsors and Collaborators

FDA Office of Orphan Products Development

More Information

No publications provided

Study ID Numbers:	FD-R-1971-01, FD-R-001971-01
Study First Received:	December 5, 2001
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00027417 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by FDA Office of Orphan Products Development:

Congenital heart defects
Hypoplastic left heart syndrome
Complete atrioventricular canal defect
Triostat
Cardiac surgery

Additional relevant MeSH terms:

Heart Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Defects, Congenital

ClinicalTrials.gov processed this record on November 09, 2009