Trial Search Results

Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Seattle Children's Hospital

Stanford Investigator(s):

Intervention(s):

  • Drug: Triostat
  • Drug: Placebo

Phase:

Phase 3

Eligibility


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

Ages Eligible for Study

N/A - 5 Months

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting