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Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass

Information source: Seattle Children's Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Congenital Heart Defects

Intervention: Triostat (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: 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.

Clinical Details

Official title: Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Time To Extubation

Secondary outcome:

ICU Length of Stay

Discharge on Oral Feeds


Duration of freedom from Extracorporeal Membrane Oxygenation (ECMO) - if applicable


Minimum age: N/A. Maximum age: 5 Months. Gender(s): Both.


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

Locations and Contacts

Los Angeles Children's Hospital, Los Angeles, California 90027, United States; Not yet recruiting
Laura Hastings, MD

Lucille Packard Children's Hospital, Palo Alto, California 94304, United States; Not yet recruiting
Stephen Roth, MD

Seattle Children's Hospital, Seattle, Washington 98105, United States; Recruiting
Jeremy J Gillis, BS, Phone: 206-884-5153, Email: jeremy.gillis@seattlechildrens.org
Michael A Portman, MD, Phone: 206-987-1014, Email: michael.portman@seattlechildrens.org
Michael Portman, MD, Principal Investigator

Additional Information

Starting date: November 2014
Last updated: March 3, 2015

Page last updated: August 23, 2015

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