Oral Triiodothyronine for Children Undergoing Cardiopulmonary Bypass in Indonesia

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cardiovascular Center Harapan Kita Hospital Indonesia
• Collaborators: CRDF Global; Dalim BioTech Co., Ltd.; Osypka Germany

Criteria

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