Oral Triiodothyronine for Infants Less Than 5 Months & Malnourished Children Undergoing Cardiopulmonary Bypass in Indonesia
Status:
Completed
Trial end date:
2015-06-01
Target enrollment:
Participant gender:
Summary
Infants and children undergoing cardiac surgery require mechanical support for circulation
called cardiopulmonary bypass. The artificial pump ensures that blood flow to the body is
maintained during surgical procedure on the heart. However, the pump circulation disrupts
regulation of thyroid hormone. This hormone is a critical regulator of heart and circulatory
function. Deficiencies in thyroid hormone adversely affect recovery of the heart after
cardiac surgery. A recent study by the principal investigator showed that supplementing
patients younger than 5 months old shortened the time spent on the ventilator (breathing
machine) after surgery. Populations undergoing heart surgery in developing countries such as
Indonesia are different than those in the U.S. and other industrial nations. For many heart
defects children undergo surgery at an older age. They are then sicker for longer periods,
and are often malnourished. These older malnourished children have lower thyroid hormone
levels even prior to surgery, and show dramatic further drops after surgery. Shortening time
on the ventilator should improve their recovery, and also improve overall availability of
resources in developing countries. The formulation of thyroid hormone provided in the U.S and
given intravenous is relatively expensive. However, a much more inexpensive formulation is
available in Indonesia, which can be given through a tube extending from the nose to the
stomach. We propose testing this formulation made in Korea, known as Tetronine, in two
vulnerable populations in Indonesia: children younger than 5 months of age, and those older
than 5 months who are malnourished. All these patients will be undergoing cardiopulmonary
bypass for congenital heart defects. This project will be an important collaboration between
U.S and Indonesian investigators. If successful, it will have a general positive impact on
care of the entire population of young children undergoing cardiac surgery in developing
countries by reducing time on the ventilator and improving access to care.
Phase:
Phase 3
Details
Lead Sponsor:
National Cardiovascular Center Harapan Kita Hospital Indonesia
Collaborators:
CRDF Global Dalim BioTech Co., Ltd. Osypka Germany