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
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.
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 StayDischarge on Oral Feeds Mortality Duration of freedom from Extracorporeal Membrane Oxygenation (ECMO) - if applicable
Eligibility
Minimum age: N/A.
Maximum age: 5 Months.
Gender(s): Both.
Criteria:
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
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