Oral Triiodothyronine for Children Undergoing Cardiopulmonary Bypass in Indonesia
Status:
Completed
Trial end date:
2015-01-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
National Cardiovascular Center Harapan Kita Hospital Indonesia
Collaborators:
CRDF Global Dalim BioTech Co., Ltd. Osypka Germany