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

NCT07194304 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-09-26

No results posted yet for this study

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.

Conditions

  • Tetralogy of Fallot (TOF)
  • Alpha-tocopherol
  • Cardiac Surgery

Interventions

DRUG

alpha-Tocopherol

patients in the intervention group received parenteral alpha-tocopherol at a dose of 4 mg/kg body weight

DRUG

Sterile Water for Injection

the control group received a placebo (sterile water for injection/aquabidest)

Sponsors & Collaborators

  • Dr Cipto Mangunkusumo General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2024-01-01
Completion
2025-06-01

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07194304 on ClinicalTrials.gov