Tetralogy of Fallot (TOF), Alpha-tocopherol, Cardiac Surgery
Conditions
Keywords
TOF, alpha-tocopherol, cardiac surgery, troponin I
Brief 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.
Interventions
DRUGalpha-Tocopherol
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)
Sponsors
Dr Cipto Mangunkusumo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 10 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum Troponin I Concentration (ng/L) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum Lactate Concentration (mmol/L) | 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. |
| Myocardial Injury Score (Histopathology, Scale 0-3) | 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. |
| Apoptotic Index (% of Apoptotic Cardiomyocytes) | 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. |
| Duration of Mechanical Ventilation (hours) | From end of surgery until extubation | Duration of postoperative mechanical ventilation will be recorded in hours. |
| Change in Serum Malondialdehyde (MDA) Concentration (ng/mL) | 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. |
| GPx expression | tissue sample is collected 15 minutes after releasing the aortic cross clamp | — |
| Intensive Care Unit Length of Stay (days) | 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. |
| Hospital Length of Stay (days) | 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. |
| Vasoactive-Inotropic Score (VIS, Scale 0-X) | 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. |
| anti-cTnI | tissue sample is collected 15 minutes after releasing the aortic cross clamp | — |
Countries
Indonesia
Outcome results
None listed