Oral Triiodothyronine for Infants Less Than 5 Months & Malnourished Children Undergoing Cardiopulmonary Bypass in Indonesia

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.

Conditions

• Postoperative; Dysfunction Following Cardiac Surgery

Interventions

DRUG

Tetronine

Oral T3 was given 1 microgram/kgBW q6h since induction of anesthesia for 11 doses (for 60 hours)

DRUG

Placebo

Placebo was sacharum lactis, given q6h since induction of anesthesia for 11 doses (for 60 hours)

Sponsors & Collaborators

• CRDF Global

  collaborator OTHER

• Osypka Germany

  collaborator UNKNOWN

• Dalim BioTech Co., Ltd.

  collaborator INDUSTRY

• National Cardiovascular Center Harapan Kita Hospital Indonesia

  lead OTHER

Principal Investigators

• Eva M Marwali, MD · National Cardiovascular Center Harapan Kita Jakarta

• Michael A Portman, MD · University of Washington

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

1 Day

Max Age

36 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-06-30

Primary Completion

2015-05-31

Completion

2015-06-30

Countries

• Indonesia

Study Locations