Oral Triiodothyronine for Children Undergoing Cardiopulmonary Bypass in Indonesia (OTICC)
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|ClinicalTrials.gov Identifier: NCT02521168|
Recruitment Status : Completed
First Posted : August 13, 2015
Last Update Posted : February 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Postoperative; Dysfunction Following Cardiac Surgery||Drug: Oral triiodothyronine Drug: Placebo||Phase 3|
The study was conducted at the cardiac paediatric cardiac intensive care unit of National Cardiovascular Center Harapan Kita. It was performed on paediatric congenital heart disease population who underwent open heart surgery with randomised, double-blind, controlled trial design. All patients with congenital heart disease, 3 years old or less, were included. Types of congenital heart disease suffered required subject to undergo surgery using cardiopulmonary bypass machine with Aristotle score of 6-9. Surgery was aimed for biventricular repair.
The sample size needed almost 200 patients with 50% is in the treatment group. This calculation was based on 90% of patients will be extubated and expected hazard ratio of corresponding treatment group is 1.7 with 5% alpha error and 20% beta error.
Patients were randomised using block randomisation procedure. The stratification factor will be age at the time of recruitment: < 6 weeks old, 6 weeks - 5 months old, > 5 months - 3 years old. Randomization will occur on the day of surgery.
The placebo - saccharum lactis - OR oral T3 (Tetronine, Dalim Biotech Korea) with the dose of 1 mcg per kg body weight were administered via nasogastric tube for every 6 hours starting from the time of anaesthesia induction until 11 doses in total (60 hours after the initial administration). Serial free T3 (FT3) and thyroid stimulating hormone (TSH) measurement were performed starting from the induction of anaesthesia until patient's discharge. Haemodynamics monitoring and echocardiography evaluation was conducted from day 1 to 3 after the surgery.
Primary analysis will be performed using Cox Proportional Hazards for time to extubation result, including terms for stratification factors (age, Aristotle score and nutrition status). Patients will be included in analysis if they were randomised and received at least one dose of study drug according to the principal of Intention-to-Treat (ITT).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||177 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Oral Triiodothyronine for Children Undergoing Cardiopulmonary Bypass in Indonesia|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||January 2015|
Experimental: Oral triiodothyronine
Oral T3 (triiodothyronine) is given 1 mcg/kg every 6 hourly through naso-gastric tube since induction of anaesthesia for 60 hours
Drug: Oral triiodothyronine
Oral triiodothyronine is given peri-operatively through naso-gastric tube
Placebo Comparator: Placebo
Placebo (saccharin lactic) is given every 6 hourly through naso-gastric tube since induction of anaesthesia for 60 hours
Placebo consist of saccharin lactis that has the same appearance as Tetronine
Other Name: Saccharin lactis
- Intubation time [ Time Frame: Until patients extubated after surgery in ICU OR died OR still intubated within 7 days ]All patients after undergoing congenital heart surgery will be supported by mechanical ventilation. Duration of this support since cross clamp off removal until after surgery will be assessed in the treatment and placebo group. Thyroid supplementation will increase the cardiac function and will make the patients extubated early than the patients without supplementation
- Number of patients with low cardiac output syndrome [ Time Frame: 6 hours, 12 hours, 18 hours, 24 hours, 48 hours post aortic cross clamp removal ]Identified patients with low cardiac output syndrome in which had clinical signs and symptoms of low cardiac output are found with without the increasing of arterial and venous gap and metabolic acidosis and this condition needs 100% of inotropic support or even more than that from the beginning of inotropic used, the use of new inotropic, mechanical support, or other manoeuvres in order to increase cardiac output (e.g pacemaker)
- Drug adverse reaction [ Time Frame: Every hourly until 12 hours post cross clamp removal, every 3 hours until 24 hours, every 6 hours until 48 hours, every 12 hours until 72 hours post cross clamp removal, and until the patients discharge from hospital ]Heart rate to evaluate tachycardia, blood pressure for hypertension, heart rate for arrhythmia, body temperature for hyperthermia
- Inotropic and vasoactive-inotropic score [ Time Frame: 1, 6, 12, 18, 24, 36, 48, 60 and 72 hours post cross clamp removal ]The amount of inotropic drugs are calculated and reviewed serially since cross clamp removal until all drugs are stopped
- Diuresis [ Time Frame: From day 1 until day 3 post surgery ]Amount of urine output per kg body weight per hour
- Fluid balance [ Time Frame: From day 1until day 3 post surgery ]Difference between input and output of the fluid per kg body weight per day
- Lactate-pyruvate ratio [ Time Frame: On induction of anaesthesia, 1 hour, 24 hours post cross clamp removal ]Lactate and pyruvate serum was obtained from central venous catheter in internal jugular vein with the distal tip catheter in the right atrium
- Ejection Fraction [ Time Frame: Day 1, 2 and 3 post surgery ]Ejection Fraction is measured by Echocardiography
- Cardiac Index [ Time Frame: Day 1, 2 and 3 post surgery ]Cardiac index is measured by Echocardiography
- Systemic Vascular Resistance Index [ Time Frame: Day 1, 2 and 3 post surgery ]Systemic Vascular Resistance Index is measured by Echocardiography
- Pulse Pressure [ Time Frame: Every hourly until 72 hours post surgery ]Difference between systolic and diastolic pressure
- Number of patients with sepsis [ Time Frame: since day 1 post surgery until patients discharge ]Amount of patients diagnosis with sepsis based on Surviving Sepsis Campaign
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02521168
|Pediatric Cardiac ICU National Cardiovascular Center Harapan Kita|
|Jakarta, DKI Jakarta, Indonesia, 11420|
|Principal Investigator:||Eva M Marwali, MD, PhD||National Cardiovascular Center Harapan Kita Jakarta|