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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
patients in the intervention group received parenteral alpha-tocopherol at a dose of 4 mg/kg body weight
the control group received a placebo (sterile water for injection/aquabidest)
Cipto Mangunkusumo Hospital
Jakarta, Indonesia
Change in Serum Troponin I Concentration (ng/L)
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.
Time frame: Before surgery, 1 hour after surgery, and 8 hours after surgery
Change in Serum Malondialdehyde (MDA) Concentration (ng/mL)
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.
Time frame: Before surgery, 1 hour after surgery, and 8 hours after surgery
Change in Serum Lactate Concentration (mmol/L)
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.
Time frame: Before surgery, 1 hour, 6 hours, 12 hours, and 24 hours after surgery
Myocardial Injury Score (Histopathology, Scale 0-3)
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.
Time frame: 15 minutes after release of the aortic cross-clamp
Apoptotic Index (% of Apoptotic Cardiomyocytes)
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.
Time frame: tissue sample is collected 15 minutes after releasing the aortic cross clamp
Duration of Mechanical Ventilation (hours)
Duration of postoperative mechanical ventilation will be recorded in hours.
Time frame: From end of surgery until extubation
anti-cTnI
Time frame: tissue sample is collected 15 minutes after releasing the aortic cross clamp
GPx expression
Time frame: tissue sample is collected 15 minutes after releasing the aortic cross clamp
Intensive Care Unit Length of Stay (days)
ICU length of stay will be recorded in days from ICU admission until ICU discharge.
Time frame: From ICU admission until ICU discharge, assessed up to 14 days
Hospital Length of Stay (days)
Hospital length of stay will be recorded in days from hospital admission until discharge.
Time frame: From hospital admission until hospital discharge, assessed up to 30 days
Vasoactive-Inotropic Score (VIS, Scale 0-X)
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.
Time frame: First 24 hours after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.