Phase 3
N=220
Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass
Congenital Heart Defects
Bottom Line
View on ClinicalTrials.gov: NCT02320669 ↗Enrolled (actual)
220
Serious AEs
10.0%
Results posted
Apr 2024
Primary outcome: Primary: Time To Extubation — 46.9; 48.0 hours — p=<.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Triostat (Drug); Placebo (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Seattle Children's Hospital
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time To Extubation |
46.9; 48.0 | <.05 sig |
| SECONDARY ICU Length of Stay |
3.5; 2.9 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Informed consent obtained
- Male and female patients <5 months (152 days) of age
- Patients undergoing cardiopulmonary bypass
Exclusion Criteria
- Known thyroid disease (Down Syndrome is not an exclusion criterion unless patient has thyroid disease)
- Trisomy 13 and 18
- Prolonged preoperative ventilator support which would not be impacted by cardiac surgery (Lung disease: bronchopulmonary dysplasia, hypoplastic lungs associated with diaphragmatic hernia)
- Any other condition as determined by the PI causing prolonged ventilator support which is unlikely to respond favorably to cardiac surgery
- Prior participation in the clinical trial
Data sourced from ClinicalTrials.gov (NCT02320669). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.