Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass

Phase 3

Completed

• Conditions: Congenital Heart Defects
• Interventions: Drug: Triostat; Drug: Placebo

• Registration Number: NCT02320669
• Lead Sponsor: Seattle Children's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-12-05
• Study First Submitted QC: 2014-12-15
• Study First Posted: 2014-12-19
• Primary Completion: 2019-10
• Study Completion: 2019-10
• Results First Submitted: 2023-02-17
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-11
• Last Update Submitted: 2024-03-11
• Results First Posted: 2024-04-09
• Last Update Posted: 2024-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Triostat	Triostat	Active Medication - Synthetic Thyroid Hormone
Placebo	Placebo	Placebo Control

Primary Outcome Measures

Name	Time	Method
Time To Extubation	30 days	time on mechanical ventilation after aortic cross clamp removal

Secondary Outcome Measures

Name	Time	Method
ICU Length of Stay	30 days	Length of stay in the ICU

Trial Locations

Locations (3)

Los Angeles Children's Hospital; 🇺🇸 Los Angeles, California, United States

Lucille Packard Children's Hospital; 🇺🇸 Palo Alto, California, United States

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States