Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass (TRICC-2)

Seattle Children's Healthcare System

Status and phase: Completed; Phase 3

Conditions: Congenital Heart Defects

Treatments: Drug: Triostat; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02320669

14798

R01FD004362-01A2

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: All

Ages: Under 5 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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220 participants in 2 patient groups, including a placebo group

Triostat

Experimental group

Description:

Active Medication - Synthetic Thyroid Hormone

Treatment:

Drug: Triostat

Placebo

Placebo Comparator group

Description:

Placebo Control

Treatment:

Drug: Placebo