drugset / Trial / NCT07194304

Effect of Parenteral Alpha-Tocopherol in the Definitive Surgery of Tetralogy of Fallot

NCT07194304

Phase 0 Completed 60 enrolled Dr Cipto Mangunkusumo General Hospital
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

EvaluationDrugModalityDoseRoute
Subject alpha-tocopherol Unknown 4 mg/kg Other

Indications