NCT02222532: I-TRICC

Tetronine (Sodium Liothyronine) for Infants & Children Undergoing Cardiopulmonary Bypass in a Middle Income Nation (OTICC Study)

Completed Phase 3 Last updated 16 February 2016

What this trial tests

Phase 3 trial testing Tetronine in Postoperative; Dysfunction Following Cardiac Surgery in 224 participants. Completed in 1 June 2015.

Timeline

1 June 2013

Primary endpoint
1 May 2015

1 June 2015

Quick facts

Lead sponsor	National Cardiovascular Center Harapan Kita Hospital Indonesia
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	224
Start date	1 June 2013
Primary completion	1 May 2015
Estimated completion	1 June 2015
Sites	1 location across Indonesia

Drugs / interventions tested

• Tetronine — full drug profile →
• Placebo

Conditions studied

• Postoperative; Dysfunction Following Cardiac Surgery — all drugs for Postoperative; Dysfunction Following Cardiac Surgery →

Sponsor

National Cardiovascular Center Harapan Kita Hospital Indonesia

Who can join

Adults 1 Day to 36 Months, any sex, with Postoperative; Dysfunction Following Cardiac Surgery. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Intubation time
  Time frame: Up to 7 days post surgery
  All patients after undergoing congenital heart surgery will be supported by mechanical ventilation. Duration of this support on mechanical ventilation after surgery will be assessed in the treatment group and placebo group. Thyroid supplementation will increase the cardiac function and will make the patients extubated early than the patients without supplementation.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Thyroid Hormone in the Pediatric Intensive Care Unit.
   Radman M, Portman MA. · · 2016 · cited 12× · PMID 31110900 · DOI 10.1055/s-0036-1583280
2. Indonesian Study: Triiodothyronine for Infants Less than 5 Months Undergoing Cardiopulmonary Bypass.
   Marwali EM, Lopolisa A, Sani AA, Rayhan M, et al · · 2022 · cited 3× · PMID 34851445 · DOI 10.1007/s00246-021-02779-8