Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2019-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Can Oral T3 Normalize Thyroid Hormone Levels Following Cardiopulmonary Bypass in Children?

NCT01780584

Low T3 Syndrome

COMPLETED PHASE2

Oral Triiodothyronine for Infants Less Than 5 Months & Malnourished Children Undergoing Cardiopulmonary Bypass in Indonesia

NCT02222532

Postoperative; Dysfunction Following Cardiac Surgery

COMPLETED PHASE3

Oral Triiodothyronine for Children Undergoing Cardiopulmonary Bypass in Indonesia

NCT02521168

Postoperative; Dysfunction Following Cardiac Surgery

COMPLETED PHASE3

Peri-operative Oral Triiodothyronine Replacement Therapy to Decrease the Risk of Transient Atrial Fibrillation After Off-pump Coronary Artery Bypass Surgery

NCT01153360

Non-thyroidal Illness Syndrome

COMPLETED NA

Use of Liquid Stable Levothyroxine in Trisomy 21 Pediatric Patients

NCT04747275

Hypothyroidism Trisomy 21

TERMINATED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Congenital Heart Defects

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Triostat

Active Medication - Synthetic Thyroid Hormone

Group Type EXPERIMENTAL

Triostat

Intervention Type DRUG

Bolus of Triiodothyronine followed by infusion for 48 hours

Placebo

Placebo Control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Bolus of Placebo followed by infusion for 48 hours

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Triostat

Bolus of Triiodothyronine followed by infusion for 48 hours

Intervention Type DRUG

Placebo

Bolus of Placebo followed by infusion for 48 hours

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

triiodothyronine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Maximum Eligible Age

5 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No