CompletedEarly Phase 1

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

Indonesia60 participantsStarted 2022-05-01

Plain-language 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.

Who can participate

Age range1 Year – 10 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of congenital heart disease Tetralogy of Fallot (ToF) * Age between 1 and 10 years * Scheduled for definitive repair of ToF using cardiopulmonary bypass (CPB) at PJT-RSCM Exclusion Criteria: * History of prior palliative surgery (e.g., Blalock-Taussig shunt) * Presence of additional congenital heart disease requiring major modification or addition of surgical procedures * History of central nervous system disorder or stroke * History of cardiopulmonary resuscitation (CPR) * Undergoing redo surgery (e.g., residual stenosis, bleeding)

What they're measuring

Change in Serum Troponin I Concentration (ng/L)

Timeframe: Before surgery, 1 hour after surgery, and 8 hours after surgery

Trial details

NCT IDNCT07194304

SponsorDr Cipto Mangunkusumo General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-01

View on ClinicalTrials.gov More Tetralogy of Fallot (TOF) trials