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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02320669
Other study ID # 14798
Secondary ID R01FD004362-01A2
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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