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NCT Number: NCT07194304

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

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.

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Key information

Conditions

Tetralogy of Fallot (TOF) Alpha-tocopherol Cardiac Surgery Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Tetralogy of Fallot

Age range

1 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Cipto Mangunkusumo Hospital

Jakarta, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

alpha-Tocopherol

Drug

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

Sterile Water for Injection

Drug

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

Primary outcomes

  1. Change in Serum Troponin I Concentration (ng/L)

    Time frame: Before surgery, 1 hour after surgery, and 8 hours after surgery

    Serum Troponin I concentration will be measured at baseline (before surgery), 1 hour after surgery, and 8 hours after surgery to assess the extent of myocardial injury associated with cardiopulmonary bypass during Tetralogy of Fallot repair.

Secondary outcomes

  1. Change in Serum Malondialdehyde (MDA) Concentration (ng/mL)

    Time frame: Before surgery, 1 hour after surgery, and 8 hours after surgery

    Serum malondialdehyde (MDA), a biomarker of oxidative stress, will be measured at baseline (before surgery), 1 hour after surgery, and 8 hours after surgery to evaluate oxidative injury associated with cardiopulmonary bypass during Tetralogy of Fallot repair.

  2. Change in Serum Lactate Concentration (mmol/L)

    Time frame: Before surgery, 1 hour, 6 hours, 12 hours, and 24 hours after surgery

    Serum lactate levels will be measured at baseline (before surgery), and at 1 hour, 6 hours, 12 hours, and 24 hours after surgery to evaluate tissue perfusion and metabolic response associated with cardiopulmonary bypass during Tetralogy of Fallot repair.

  3. Myocardial Injury Score (Histopathology, Scale 0-3)

    Time frame: 15 minutes after release of the aortic cross-clamp

    Myocardial tissue injury will be assessed from biopsy samples collected 15 minutes after release of the aortic cross-clamp. Injury will be graded on a histopathological scale ranging from 0 to 3, where 0 = no injury and 3 = severe injury. Higher scores indicate worse myocardial damage.

  4. Apoptotic Index (% of Apoptotic Cardiomyocytes)

    Time frame: tissue sample is collected 15 minutes after releasing the aortic cross clamp

    The apoptotic index will be calculated from myocardial tissue samples collected 15 minutes after release of the aortic cross-clamp. Sections are stained with TUNEL and examined at 40× magnification across 6 hotspot areas. The index is expressed as the percentage of TUNEL-positive cardiomyocytes per 100 cardiomyocytes. The scale ranges from 0% (no apoptosis) to 100% (all cells apoptotic). Higher values indicate greater myocardial apoptosis.

  5. Duration of Mechanical Ventilation (hours)

    Time frame: From end of surgery until extubation

    Duration of postoperative mechanical ventilation will be recorded in hours.

  6. anti-cTnI

    Time frame: tissue sample is collected 15 minutes after releasing the aortic cross clamp

  7. GPx expression

    Time frame: tissue sample is collected 15 minutes after releasing the aortic cross clamp

  8. Intensive Care Unit Length of Stay (days)

    Time frame: From ICU admission until ICU discharge, assessed up to 14 days

    ICU length of stay will be recorded in days from ICU admission until ICU discharge.

  9. Hospital Length of Stay (days)

    Time frame: From hospital admission until hospital discharge, assessed up to 30 days

    Hospital length of stay will be recorded in days from hospital admission until discharge.

  10. Vasoactive-Inotropic Score (VIS, Scale 0-X)

    Time frame: First 24 hours after surgery

    Vasoactive-Inotropic Score (VIS) will be calculated to quantify the amount of vasoactive support required after surgery. The VIS scale ranges from 0 to an open-ended maximum value; higher scores indicate greater need for vasoactive support and worse hemodynamic status.

Sponsors and collaborators

Lead sponsor

Dr Cipto Mangunkusumo General Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Sep 26, 2025
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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