Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified February 2024 by Seattle Children's Hospital
Sponsor
Seattle Children's Hospital
Information Provided by (Responsible Party)
Michael Portman
Clinicaltrials.gov Identifier
NCT02320669
Other Study ID Numbers:
14798
First Submitted
December 4, 2014
First Posted
December 18, 2014
Results First Posted
February 16, 2023
Last Update Posted
April 8, 2024
Last Verified
February 2024

ClinicalTrials.gov processed this data on March 2024. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Congenital Heart Defects
Drug: TriostatDrug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment220 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitlePhase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass
Study Start DateOctober 31, 2014
Actual Primary Completion DateSeptember 30, 2019
Actual Study Completion DateSeptember 30, 2019

Groups and Cohorts

Group/CohortIntervention/Treatment
Triostat
Active Medication - Synthetic Thyroid Hormone
Drug: Triostat
Bolus of Triiodothyronine followed by infusion for 48 hours
Placebo
Placebo Control
Drug: Placebo
Bolus of Placebo followed by infusion for 48 hours

Outcome Measures

Primary Outcome Measures
  1. Time To Extubation
    time on mechanical ventilation after aortic cross clamp removal
Secondary Outcome Measures
  1. ICU Length of Stay
    Length of stay in the ICU

Eligibility Criteria

Ages Eligible for Study(Child)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsSeattle Children's Hospital
Locations
Los Angeles Children's Hospital | Los Angeles California, United States, 90027Lucille Packard Children's Hospital | Palo Alto California, United States, 94304Seattle Children's Hospital | Seattle Washington, United States, 98105
Investigators
Principal Investigator: Michael Portman, MD, Seattle Children's Hospital
Study Documents (Full Text)
Documents provided by Seattle Children's Hospital: Study Protocol and Statistical Analysis Plan  September 29, 2015