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

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cardiovascular Center Harapan Kita Hospital Indonesia

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