drugset / Trial / NCT07194304
Effect of Parenteral Alpha-Tocopherol in the Definitive Surgery of Tetralogy of Fallot
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Introduction: Tetralogy of Fallot (ToF) correction with cardiopulmonary bypass (CPB) poses a risk of ischemia-reperfusion injury, especially in cyanotic myocardium. Alpha-tocopherol, a potent antioxidant, may reduce myocardial damage during surgery. Methods: This randomized controlled trial included 58 ToF patients aged 1-10 years undergoing definitive surgery with CPB at Integrated Heart Center, Cipto Mangunkusumo Hospital. Patients were randomly assigned to receive either parenteral alpha-tocopherol (4 mg/kg) or placebo at the initiation of CPB. The primary outcome was postoperative troponin I level.
Timeline
- Start
- 2022-05-01
- Primary completion
- 2024-01-01
- Completion
- 2025-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | alpha-tocopherol | Unknown | 4 mg/kg | Other |