Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass

Status:	Recruiting
Conditions:	Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	Any
Updated:	7/21/2018
Start Date:	November 2014
End Date:	October 2019
Contact:	Michael Portman, MD
Email:	michael.portman@seattlechildrens.org
Phone:	206-987-1014

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. Funding Source - FDA OOPD.

Inclusion Criteria:

1. Informed consent obtained

2. Male and female patients <5 months (152 days) of age

3. Patients undergoing cardiopulmonary bypass

Exclusion Criteria:

1. Known thyroid disease (Down Syndrome is not an exclusion criterion unless patient has
thyroid disease)

2. Trisomy 13 and 18

3. Prolonged preoperative ventilator support which would not be impacted by cardiac
surgery (Lung disease: bronchopulmonary dysplasia, hypoplastic lungs associated with
diaphragmatic hernia)

4. Any other condition as determined by the PI causing prolonged ventilator support which
is unlikely to respond favorably to cardiac surgery

5. Prior participation in the clinical trial

We found this trial at

sites

Lucille Packard Children's Hospital

Palo Alto, California 94304

Principal Investigator: Stephen Roth, MD

Phone: 650-725-8349

from

Palo Alto, CA