Status:
UNKNOWN
Thiamine Influenced on Substrate Energy Effectiveness in Indonesian Children Undergoing Cardiopulmonary Bypass
Lead Sponsor:
National Cardiovascular Center Harapan Kita Hospital Indonesia
Conditions:
Thiamine Deficiency
Congenital Heart Disease
Eligibility:
All Genders
1-2 years
Phase:
PHASE4
Brief Summary
This is a randomized, double-blind, controlled trial design. It was conducted with a main purpose of evaluating the effect of thiamine supplementation on serum lactate and lactate-pyruvate ratio after...
Detailed Description
All patients who undergo open cardiac surgery for their congenital heart disease on the research period will be recruited consecutively and evaluated according to the study criteria. Parents or guardi...
Eligibility Criteria
Inclusion
- All patients with congenital heart disease, 2 years old or less, with moderate to severe malnutrition are included. Types of congenital heart disease suffered required subject to undergo surgery using cardiopulmonary bypass machine with Aristotle score of 6-9.
Exclusion
- Body weight of less than 2 kg at the study period
- Suffering from pre-surgical tachyarrhythmia or other types of arrhythmias
- Pre-surgical sepsis
- Serum creatinine of more than 2 mg/dL
- Diagnosed with thyroid abnormalities prior to the surgery
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04453761
Start Date
July 1 2018
End Date
December 1 2022
Last Update
July 1 2020
Active Locations (1)
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1
National Cardiovascular Center Harapan Kita
Jakarta, DKI Jakarta, Indonesia, 11420