Status:
COMPLETED
Oral Triiodothyronine for Infants Less Than 5 Months & Malnourished Children Undergoing Cardiopulmonary Bypass in Indonesia
Lead Sponsor:
National Cardiovascular Center Harapan Kita Hospital Indonesia
Collaborating Sponsors:
CRDF Global
Osypka Germany
Conditions:
Postoperative; Dysfunction Following Cardiac Surgery
Eligibility:
All Genders
1-36 years
Phase:
PHASE3
Brief 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 s...
Detailed Description
Methods Study Overview and Objectives We will perform a randomized double blinded placebo controlled trial in Indonesian children under 3 years of age, who are undergoing cardiopulmonary bypass proce...
Eligibility Criteria
Inclusion
- Children undergoing cardiopulmonary bypass
- Age 3 years old or less
- Aristotle score 6 and above
- Total correction or biventricular repair
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT02222532
Start Date
June 1 2013
End Date
June 1 2015
Last Update
February 17 2016
Active Locations (1)
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1
Pediatric Cardiac ICU National Cardiovascular Center Harapan Kita
Jakarta, DKI Jakarta, Indonesia, 11420