Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass

Congenital Heart Defects Clinical Trial

— TRICC-2  

Official title:

Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02320669
• Other study ID #: 14798
• Secondary ID: R01FD004362-01A2
• Status: Completed
• Phase: Phase 3
• Start date: November 2014
• Est. completion date: October 2019

Study information

• Verified date: March 2024
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Months

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

Related Conditions & MeSH terms

• Congenital Heart Defects
• Heart Defects, Congenital

Intervention

Drug:
• Triostat
Bolus of Triiodothyronine followed by infusion for 48 hours
• Placebo
Bolus of Placebo followed by infusion for 48 hours

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Portman MA, Slee AE, Roth SJ, Radman M, Olson AK, Mainwaring RD, Kamerkar A, Nuri M, Hastings L; TRICC Investigators. Triiodothyronine Supplementation in Infants Undergoing Cardiopulmonary Bypass: A Randomized Controlled Trial. Semin Thorac Cardiovasc Sur — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time To Extubation	time on mechanical ventilation after aortic cross clamp removal	30 days
Secondary	ICU Length of Stay	Length of stay in the ICU	30 days