Oral Triiodothyronine for Children Undergoing Cardiopulmonary Bypass in Indonesia (NCT02521168) | Clinical Trial Compass
CompletedPhase 3
Oral Triiodothyronine for Children Undergoing Cardiopulmonary Bypass in Indonesia
Indonesia177 participantsStarted 2013-07
Plain-language summary
A condition of decreased serum T3 level in children after cardiac surgery using cardiopulmonary bypass has been commonly recognized as euthyroid sick syndrome (ESS). This syndrome has been closely associated with low cardiac output syndrome after heart surgery. The unique characteristics of pediatric patients with congenital heart disease (CHD) in Indonesia have caused ESS to arise in the population even before surgical managements. Thyroid hormones increase cardiac function, respiration and diuresis. Increased myocardial function occurred through the improvement of mitochondrial effectiveness as the body energy source by utilizing effective energy substrates, lactate and pyruvate. Prevention of decreased serum thyroid hormones level by T3 supplementation could be clinically beneficial. Intravenous T3 unit dose is very expensive and inapplicable for daily use. In adult studies, oral T3 was found to be effective for the prevention of decreased serum T3 levels; similar study on pediatric population, however, has not been elucidated.
Who can participate
Age range
1 Day – 36 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Children undergoing cardiopulmonary bypass
* Age 36 months old or less
* Aristotle score 6-9
* Total correction or biventricular repair
Exclusion Criteria:
* Single ventricle defects
* Body weight less than 2 kg at the time of recruitment
* Presentation with sepsis
* Tachyarrhythmia or any other arrhythmia before surgery
* Creatinine level of more than 2 mg/dl
* Known thyroid disease
* Known lung abnormalities (including infection) before surgery
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested oral triiodothyronine — a thyroid hormone — given to children before heart surgery using a heart-lung bypass machine, so could you explain why thyroid hormone levels drop during that kind of surgery and whether that's a concern for my child's specific procedure?
2The main thing this completed Phase 3 trial measured was how long children needed to stay on a breathing machine after surgery — based on what you know about results from studies like this one, is there any evidence that giving thyroid hormone beforehand actually shortens time on the ventilator?
3Since this trial was conducted in Indonesia and is now completed, is the approach it studied — giving oral T3 before bypass surgery — something that's used or being considered at our hospital, or are there other protocols here that address the same issue?
4This was a Phase 3 trial, which means safety and dosing had already been studied in earlier phases — does that give us a reasonably clear picture of the risks of giving a child supplemental thyroid hormone around the time of cardiac surgery, and are there any side effects I should know about?
5Instead of a trial-based approach, what is the standard of care at this hospital for managing thyroid hormone changes in children undergoing heart bypass surgery, and is that something we should be discussing as part of my child's surgical plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intubation time
Timeframe: Until patients extubated after surgery in ICU OR died OR still intubated within 7 days
Trial details
NCT IDNCT02521168
SponsorNational Cardiovascular Center Harapan Kita Hospital Indonesia