Postoperative; Dysfunction Following Cardiac Surgery Clinical Trial
— I-TRICCOfficial title:
Tetronine (Sodium Liothyronine) for Infants & Children Undergoing Cardiopulmonary Bypass in a Middle Income Nation (OTICC Study)
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.
Status | Completed |
Enrollment | 224 |
Est. completion date | June 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 36 Months |
Eligibility |
Inclusion Criteria: - Children undergoing cardiopulmonary bypass - Age 3 years old or less - Aristotle score 6 and above - 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 (incl. infection) before surgery. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Indonesia | Pediatric Cardiac ICU National Cardiovascular Center Harapan Kita | Jakarta | DKI Jakarta |
Lead Sponsor | Collaborator |
---|---|
National Cardiovascular Center Harapan Kita Hospital Indonesia | CRDF Global, Dalim BioTech Co., Ltd., Osypka Germany |
Indonesia,
Marwali EM, Boom CE, Sakidjan I, Santoso A, Fakhri D, Kartini A, Kekalih A, Schwartz SM, Haas NA. Oral triiodothyronine normalizes triiodothyronine levels after surgery for pediatric congenital heart disease*. Pediatr Crit Care Med. 2013 Sep;14(7):701-8. doi: 10.1097/PCC.0b013e3182917f87. — View Citation
Portman MA, Slee A, Olson AK, Cohen G, Karl T, Tong E, Hastings L, Patel H, Reinhartz O, Mott AR, Mainwaring R, Linam J, Danzi S; TRICC Investigators. Triiodothyronine Supplementation in Infants and Children Undergoing Cardiopulmonary Bypass (TRICC): a multicenter placebo-controlled randomized trial: age analysis. Circulation. 2010 Sep 14;122(11 Suppl):S224-33. doi: 10.1161/CIRCULATIONAHA.109.926394. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Fluid balance | Fluid balances include amount of diuresis, chest drain production, peritoneal dialysis, and the use of diuretics. | Until day 3 | No |
Other | Hemodynamic parameter | Hemodynamic parameter such blood pressure, heart rate, heart rhythm, and body temperature | Every hourly until 12 hours post Cross clamp removal, every 3 hours until 24 hours, every 6 hours until 48 hours and every 12 hours until 72 hours post cross clamp removal, | Yes |
Other | Low cardiac output syndrome | Low cardiac output in which clinical sign and symptoms of low cardiac output are found with or without the increasing of arterial and venous saturation gap and metabolic acidosis and the condition needs 100% inotropic support or even more than that from the beginning of inotropic used, the use of new inotropic, mechanical support, or other maneuvers in order to increase cardiac output (e.g pacemaker) | 6 hours, 12 hours, 18 hours, 24 hours and 48 hours post aortic cross clamp removal | Yes |
Other | Ejection fraction | Ejection fraction is measured by Echocardiography | Day 1, 2 and 3 after surgery | Yes |
Other | Cardiac output | Cardiac output is measured by echocardiography | Day 1, 2 and 3 post surgery | Yes |
Other | Systemic vascular resistance index (SVRI) | SVRI is measured by echocardiography | Day 1, 2 and 3 after surgery | Yes |
Primary | Intubation time | 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. | Up to 7 days post surgery | Yes |
Secondary | Inotropic score and vasoactive-inotropic score | The amount of inotropic drugs are calculated and reviewed serially since cross clamp removal until all drugs are stopped. | 1, 6, 12, 18, 24, 36, 48, 60 and 72 hours post Cross clamp removal | Yes |
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