Congenital Heart Disease Clinical Trial
Official title:
Thiamine Influenced on Substrate Energy Effectiveness in Indonesian Children Undergoing Congenital Heart Disease Surgery With Cardiopulmonary Bypass Procedure and Oral Thyroid Supplementation
Verified date | June 2020 |
Source | National Cardiovascular Center Harapan Kita Hospital Indonesia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 surgery as direct indicators of tissue perfusion and indirect markers of energy substrate availability for effective mitochondrial function and intubation time as clinical outcome.
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | December 1, 2022 |
Est. primary completion date | December 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Month to 2 Years |
Eligibility |
Inclusion Criteria: 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 Criteria: 1. Body weight of less than 2 kg at the study period 2. Suffering from pre-surgical tachyarrhythmia or other types of arrhythmias 3. Pre-surgical sepsis 4. Serum creatinine of more than 2 mg/dL 5. Diagnosed with thyroid abnormalities prior to the surgery |
Country | Name | City | State |
---|---|---|---|
Indonesia | National Cardiovascular Center Harapan Kita | Jakarta | DKI Jakarta |
Lead Sponsor | Collaborator |
---|---|
National Cardiovascular Center Harapan Kita Hospital Indonesia |
Indonesia,
Luger M, Hiesmayr M, Köppel P, Sima B, Ranz I, Weiss C, König J, Luger E, Kruschitz R, Ludvik B, Schindler K. Influence of intravenous thiamine supplementation on blood lactate concentration prior to cardiac surgery: A double-blinded, randomised controlle — View Citation
Marwali EM, Boom CE, Budiwardhana N, Fakhri D, Roebiono PS, Santoso A, Sastroasmoro S, Slee A, Portman MA. Oral Triiodothyronine for Infants and Children Undergoing Cardiopulmonary Bypass. Ann Thorac Surg. 2017 Aug;104(2):688-695. doi: 10.1016/j.athoracsu — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate the effect of thiamine supplementation to pyruvate levels | Comparing the lab parameter indicate pyruvate levels | at 6 hours post cross clamp removal | |
Secondary | Evaluate the effect of thiamine supplementation to cardiac output. | Measuring Cardiac output | Within 1 days of surgery |
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