Phase 2
Completed N=45
Can Oral T3 Normalize Thyroid Hormone Levels Following Cardiopulmonary Bypass in Children?
Low T3 Syndrome
Source: ClinicalTrials.gov NCT01780584 ↗
Enrolled (actual)
45
Serious AEs
6.7%
Results posted
Mar 2013
Primary outcomePrimary: Free T3 (FT3) Levels — 3.6; 4.5; 3.9; 3.6 pg/ml — p=<0.05
Summary
Low triiodothyronine (T3) syndrome defines as decrease of T3 levels during critically ill. This decrease of T3 levels was observed after congenital heart surgery using cardiopulmonary bypass. Previous largest study,Triiodothyronine for Infants and Children Undergoing Cardiopulmonary bypass (TRICC) study showed T3 supplementation decreased time to extubation for infants less than 5 months undergoing cardiopulmonary bypass. Intravenous regiment was known effective in maintaining T3 levels during pediatric cardiac surgery. This drug preparation however is not commonly used in many countries due to the relatively high costs and/or the simple lack of availability. The use of oral T3 to treat postoperative low T3 levels in pediatric patients has not been reported so far, although recent adult studies showed benefit in using oral T3 after cardiac surgery. The purpose of this study was to determine if oral T3 supplementation could prevent the decline of serum T3 in children less than 2 years of age undergoing congenital heart surgery using CPB.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Free T3 (FT3) Levels |
3.6; 4.5; 3.9; 3.6; 4.1; 4.3 | <0.05 sig |
| SECONDARY Number of Patients With Possible Side Effects of Thyroid Hormone Supplementation Particularly Suggesting Hyperthyroid Symptoms. |
0; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Patients between 0-2 years of age
- Aristotle score of 6 and above
- underwent cardiac surgery using cardiopulmonary bypass
Exclusion Criteria
- birth weight less than 2 kg for neonates
- preoperative tachyarrhythmia or need for anti arrhythmic treatment
- clinical sepsis confirmed by culture
- preoperative renal insufficiency
- known thyroid and metabolic disorder
- any contraindication for oral T3 administration
Data sourced from ClinicalTrials.gov (NCT01780584). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.