Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-01-05 @ 6:13 PM
Study NCT ID:
NCT07194304
Status:
COMPLETED
Last Update Posted:
2025-09-26
First Post:
2025-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Parenteral Alpha-Tocopherol in the Definitive Surgery of Tetralogy of Fallot
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013771', 'term': 'Tetralogy of Fallot'}], 'ancestors': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D024502', 'term': 'alpha-Tocopherol'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D024505', 'term': 'Tocopherols'}, {'id': 'D014810', 'term': 'Vitamin E'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2025-07-04', 'studyFirstSubmitQcDate': '2025-09-18', 'lastUpdatePostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Serum Troponin I Concentration (ng/L)', 'timeFrame': 'Before surgery, 1 hour after surgery, and 8 hours after surgery', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in Serum Malondialdehyde (MDA) Concentration (ng/mL)', 'timeFrame': 'Before surgery, 1 hour after surgery, and 8 hours after surgery', 'description': '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.'}, {'measure': 'Change in Serum Lactate Concentration (mmol/L)', 'timeFrame': 'Before surgery, 1 hour, 6 hours, 12 hours, and 24 hours after surgery', 'description': '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.'}, {'measure': 'Myocardial Injury Score (Histopathology, Scale 0-3)', 'timeFrame': '15 minutes after release of the aortic cross-clamp', 'description': '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.'}, {'measure': 'Apoptotic Index (% of Apoptotic Cardiomyocytes)', 'timeFrame': 'tissue sample is collected 15 minutes after releasing the aortic cross clamp', 'description': '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.'}, {'measure': 'Duration of Mechanical Ventilation (hours)', 'timeFrame': 'From end of surgery until extubation', 'description': 'Duration of postoperative mechanical ventilation will be recorded in hours.'}, {'measure': 'anti-cTnI', 'timeFrame': 'tissue sample is collected 15 minutes after releasing the aortic cross clamp'}, {'measure': 'GPx expression', 'timeFrame': 'tissue sample is collected 15 minutes after releasing the aortic cross clamp'}, {'measure': 'Intensive Care Unit Length of Stay (days)', 'timeFrame': 'From ICU admission until ICU discharge, assessed up to 14 days', 'description': 'ICU length of stay will be recorded in days from ICU admission until ICU discharge.'}, {'measure': 'Hospital Length of Stay (days)', 'timeFrame': 'From hospital admission until hospital discharge, assessed up to 30 days', 'description': 'Hospital length of stay will be recorded in days from hospital admission until discharge.'}, {'measure': 'Vasoactive-Inotropic Score (VIS, Scale 0-X)', 'timeFrame': 'First 24 hours after surgery', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TOF', 'alpha-tocopherol', 'cardiac surgery', 'troponin I'], 'conditions': ['Tetralogy of Fallot (TOF)', 'Alpha-tocopherol', 'Cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'Introduction:\n\nTetralogy 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.\n\nMethods:\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of congenital heart disease Tetralogy of Fallot (ToF)\n* Age between 1 and 10 years\n* Scheduled for definitive repair of ToF using cardiopulmonary bypass (CPB) at PJT-RSCM\n\nExclusion Criteria:\n\n* History of prior palliative surgery (e.g., Blalock-Taussig shunt)\n* Presence of additional congenital heart disease requiring major modification or addition of surgical procedures\n* History of central nervous system disorder or stroke\n* History of cardiopulmonary resuscitation (CPR)\n* Undergoing redo surgery (e.g., residual stenosis, bleeding)'}, 'identificationModule': {'nctId': 'NCT07194304', 'briefTitle': 'Effect of Parenteral Alpha-Tocopherol in the Definitive Surgery of Tetralogy of Fallot', 'organization': {'class': 'OTHER', 'fullName': 'Dr Cipto Mangunkusumo General Hospital'}, 'officialTitle': 'Effect of Parenteral Alpha-Tocopherol in the Definitive Surgery of Tetralogy of Fallot', 'orgStudyIdInfo': {'id': 'KET-273/UN2.F1/ETIK/PPM.00.02/'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'alpha-tocopherol', 'description': 'assigned to receive either parenteral alpha-tocopherol (4 mg/kg)', 'interventionNames': ['Drug: alpha-Tocopherol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'sterile water for injection', 'description': 'the control group received a placebo (sterile water for injection/aquabidest)', 'interventionNames': ['Drug: Sterile Water for Injection']}], 'interventions': [{'name': 'alpha-Tocopherol', 'type': 'DRUG', 'description': 'patients in the intervention group received parenteral alpha-tocopherol at a dose of 4 mg/kg body weight', 'armGroupLabels': ['alpha-tocopherol']}, {'name': 'Sterile Water for Injection', 'type': 'DRUG', 'description': 'the control group received a placebo (sterile water for injection/aquabidest)', 'armGroupLabels': ['sterile water for injection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jakarta', 'country': 'Indonesia', 'facility': 'Cipto Mangunkusumo Hospital', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr Cipto Mangunkusumo General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Cardiothoracic Surgeon', 'investigatorFullName': 'Suprayitno Wardoyo', 'investigatorAffiliation': 'Dr Cipto Mangunkusumo General Hospital'}}}}