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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| alpha-tocopherol | Experimental | assigned to receive either parenteral alpha-tocopherol (4 mg/kg) |
|
| sterile water for injection | Placebo Comparator | the control group received a placebo (sterile water for injection/aquabidest) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alpha-Tocopherol | Drug | patients in the intervention group received parenteral alpha-tocopherol at a dose of 4 mg/kg body weight |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Before surgery, 1 hour after surgery, and 8 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Before surgery, 1 hour after surgery, and 8 hours after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cipto Mangunkusumo Hospital | Jakarta | Indonesia |
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| ID | Term |
|---|---|
| D013771 | Tetralogy of Fallot |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D024502 | alpha-Tocopherol |
| D007267 | Injections |
| ID | Term |
|---|---|
| D024505 | Tocopherols |
| D014810 | Vitamin E |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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| Sterile Water for Injection | Drug | the control group received a placebo (sterile water for injection/aquabidest) |
|
| 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. | 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. | 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. | 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. | From end of surgery until extubation |
| anti-cTnI | tissue sample is collected 15 minutes after releasing the aortic cross clamp |
| GPx expression | 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. | 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. | 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. | First 24 hours after surgery |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |