Oral Triiodothyronine for Infants Less Than 5 Months & Malnourished Children Undergoing Cardiopulmonary Bypass in Indonesia (I-TRICC)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02222532 |
Recruitment Status :
Completed
First Posted : August 21, 2014
Last Update Posted : February 17, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Postoperative; Dysfunction Following Cardiac Surgery | Drug: Tetronine Drug: Placebo | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 224 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Tetronine (Sodium Liothyronine) for Infants & Children Undergoing Cardiopulmonary Bypass in a Middle Income Nation (OTICC Study) |
Study Start Date : | June 2013 |
Actual Primary Completion Date : | May 2015 |
Actual Study Completion Date : | June 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Tetronine
Oral T3 (Tetronine) is given 1 mcg/kg every 6 hourly through naso-gastric tube since induction of anesthesia for 60 hours
|
Drug: Tetronine
Oral T3 was given 1 microgram/kgBW q6h since induction of anesthesia for 11 doses (for 60 hours)
Other Name: Oral Triidothyronine (T3) |
Placebo Comparator: Placebo
Placebo (saccharin lactic) is given every 6 hourly through naso-gastric tube since induction of anesthesia for 60 hours
|
Drug: Placebo
Placebo was sacharum lactis, given q6h since induction of anesthesia for 11 doses (for 60 hours)
Other Name: Saccharin Lactic |
- 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.
- Inotropic score 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.
- Fluid balance [ Time Frame: Until day 3 ]Fluid balances include amount of diuresis, chest drain production, peritoneal dialysis, and the use of diuretics.
- Hemodynamic parameter [ Time Frame: 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, ]Hemodynamic parameter such blood pressure, heart rate, heart rhythm, and body temperature
- Low cardiac output syndrome [ Time Frame: 6 hours, 12 hours, 18 hours, 24 hours and 48 hours post aortic cross clamp removal ]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)
- Ejection fraction [ Time Frame: Day 1, 2 and 3 after surgery ]Ejection fraction is measured by Echocardiography
- Cardiac output [ Time Frame: Day 1, 2 and 3 post surgery ]Cardiac output is measured by echocardiography
- Systemic vascular resistance index (SVRI) [ Time Frame: Day 1, 2 and 3 after surgery ]SVRI is measured by echocardiography

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 1 Day to 36 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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): NCT02222532
Indonesia | |
Pediatric Cardiac ICU National Cardiovascular Center Harapan Kita | |
Jakarta, DKI Jakarta, Indonesia, 11420 |
Principal Investigator: | Eva M Marwali, MD | National Cardiovascular Center Harapan Kita Jakarta | |
Study Chair: | Michael A Portman, MD | University of Washington |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Eva M Marwali,MD, MD, National Cardiovascular Center Harapan Kita Hospital Indonesia |
ClinicalTrials.gov Identifier: | NCT02222532 |
Other Study ID Numbers: |
GITX-14-60143-0 |
First Posted: | August 21, 2014 Key Record Dates |
Last Update Posted: | February 17, 2016 |
Last Verified: | February 2016 |
tetronine congenital heart disease cardiopulmonary bypass euthyroid sick syndrome |