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

March 11, 2024 updated by: Michael Portman, Seattle Children's Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Los Angeles Children's Hospital
      • Palo Alto, California, United States, 94304
        • Lucille Packard Children's Hospital
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 5 months (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo Control
Drug: Placebo
Bolus of Placebo followed by infusion for 48 hours
Experimental: Triostat
Active Medication - Synthetic Thyroid Hormone
Drug: Triostat
Bolus of Triiodothyronine followed by infusion for 48 hours
Other Names:
  • triiodothyronine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time To Extubation
Time Frame: 30 days
time on mechanical ventilation after aortic cross clamp removal
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU Length of Stay
Time Frame: 30 days
Length of stay in the ICU
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seattle Children's Hospital

Investigators

  • Principal Investigator: Michael Portman, MD, Seattle Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

December 5, 2014

First Submitted That Met QC Criteria

December 15, 2014

First Posted (Estimated)

December 19, 2014

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14798
  • R01FD004362-01A2 (U.S. FDA Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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