Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-28 @ 12:57 AM
Study NCT ID:
NCT07254468
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-28
First Post:
2025-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Cardiovascular Autonomic Neuropathy on AKI and Outcomes in Isolated CABG Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-01', 'size': 399124, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2025-11-25T04:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 884}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2025-11-25', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Acute Kidney Injury (AKI)', 'timeFrame': 'Postoperative 7 days', 'description': 'AKI will be assessed according to KDIGO criteria using serum creatinine, BUN, GFR values, and urine output within the first 7 days postoperatively.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiovascular Autonomic Neuropathy (CAN)', 'Acute Kidney Injury (AKI)', 'Coronary Artery Bypass Graft (CABG)'], 'conditions': ['Acute Kidney Injury (AKI)', 'Coronary Artery Bypass Graft (CABG)', 'Cardiovascular Autonomic Neuropathy (CAN)', 'Postoperative Outcomes']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://doi.org/10.1016/j.jdiacomp.2024.108802', 'label': 'Systematic review on the association between diabetic peripheral neuropathy and cardiac autonomic neuropathy.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the effects of Cardiovascular Autonomic Neuropathy (CAN) on Acute Kidney Injury (AKI) and clinical outcomes in patients undergoing isolated Coronary Artery Bypass Graft (CABG) surgery requiring extracorporeal circulation(ECC).\n\nPreoperative data including demographics, comorbidities, kidney function tests, hemodynamic parameters, and baseline regional cerebral oxygen saturation (rSO2) will be recorded. Intraoperative data will include hemodynamics, urine output, blood gases, cardiopulmonary bypass and aortic cross-clamp times, cardioplegia details, number of coronary anastomoses, and rSO2 changes at defined time points.\n\nPostoperatively, kidney function, neurological status, mechanical ventilation duration, inotropic drug use, transfusion requirements, complications, ICU and hospital length of stay, and mortality will be evaluated. Acute Kidney Injury will be classified according to KDIGO criteria.\n\nThe primary objective is to analyze the effect of CAN on AKI. Secondary objectives include assessing the impact of CAN on other clinical outcomes and exploring the relationship between CAN and intraoperative cerebral oxygen changes.\n\nThis study has been approved by the Acıbadem University and Acıbadem Healthcare Institutions Medical Research Ethics Committee (ATADEK) and will be conducted following ethical principles and good clinical practice.', 'detailedDescription': "This is a prospective, multicenter study investigating the effects of Cardiovascular Autonomic Neuropathy (CAN) on Acute Kidney Injury (AKI) and other clinical outcomes in adult patients undergoing isolated Coronary Artery Bypass Graft (CABG) surgery with planned extracorporeal circulation (ECC). The study aims to determine whether CAN is associated with AKI incidence and other postoperative outcomes.\n\nStudy Population:\n\nAdults aged 18 years or older scheduled for elective isolated CABG surgery with planned ECC.\n\nInclusion Criteria:\n\nElective isolated CABG surgery Age ≥18 years\n\nExclusion Criteria:\n\nEmergency or revision surgeries\n\nOrthopedic conditions preventing standing tests\n\nChronic respiratory diseases affecting test reliability (COPD, asthma, chronic bronchitis)\n\nUncontrolled hypertension\n\nUse of antiarrhythmic drugs affecting heart rate-based tests\n\nChronic kidney failure\n\nPreoperative Assessment:\n\nCAN diagnosis using Valsalva maneuver, sitting-to-standing test, and cold/heat test (positive if ≥2 tests are abnormal).\n\nCollection of demographic data, comorbidities, laboratory tests (BUN, creatinine, GFR, ), hemodynamic parameters, and baseline regional cerebral oxygen saturation (rSO2).\n\nIntraoperative Monitoring:\n\nHemodynamic parameters, urine output, blood gases, cardiopulmonary bypass and aortic cross-clamp times, and number of coronary anastomoses recorded.\n\nRegional cerebral oxygen saturation (rSO2) continuously monitored during ECC, with values recorded for analysis but not used for clinical decisions.\n\nMean arterial pressure maintained at 60-100 mmHg; crystalloids infused at ≥100 ml/h; ephedrine administered if MAP \\<60 mmHg.\n\nPostoperative Evaluation:\n\nKidney function monitored at 24h, 48h, and 7 days postoperatively using KDIGO criteria.\n\nEvaluation of neurological outcomes, mechanical ventilation duration, inotropic support, transfusion requirements, postoperative complications (reoperation, mediastinitis, myocardial infarction), ICU and hospital length of stay, and mortality.\n\nStudy Objectives:\n\nPrimary: Assess the effect of CAN on AKI incidence.\n\nSecondary: Evaluate CAN's impact on other clinical outcomes\n\nEthics and Compliance:\n\nApproved by Acıbadem University and Acıbadem Healthcare Institutions Medical Research Ethics Committee (ATADEK), approval number 2020-21/13.\n\nConducted according to ethical principles and Good Clinical Practice (GCP) standards."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study includes adult patients (≥18 years old) scheduled for elective isolated Coronary Artery Bypass Graft (CABG) surgery with planned extracorporeal circulation (ECC). Participants will be evaluated preoperatively for cardiovascular autonomic neuropathy (CAN) using standardized tests. Patients with chronic kidney failure, severe chronic respiratory disease, uncontrolled hypertension, or conditions preventing autonomic testing are excluded. Both male and female adults are eligible, and all participants must provide informed consent.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 years or older\n\nScheduled for elective isolated Coronary Artery Bypass Graft (CABG) surgery with planned extracorporeal circulation (ECC)\n\nProvide informed consent\n\nExclusion Criteria:Emergency or revision CABG surgeries\n\nChronic kidney failure or dialysis\n\nSevere chronic respiratory disease (COPD, asthma, chronic bronchitis) affecting test reliability\n\nUncontrolled hypertension\n\nUse of antiarrhythmic drugs affecting heart rate-based autonomic tests\n\nOrthopedic or neurological conditions preventing standing tests\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07254468', 'acronym': 'CAN-AKI-CABG', 'briefTitle': 'Effect of Cardiovascular Autonomic Neuropathy on AKI and Outcomes in Isolated CABG Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Akdeniz University'}, 'officialTitle': 'Effects of Cardiovascular Autonomic Neuropathy (CAN) on Acute Kidney Injury and Clinical Outcomes in Patients Undergoing Isolated Coronary Artery Bypass Surgery', 'orgStudyIdInfo': {'id': 'CAN_AKI_STUDY'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CABG Surgery Cohort', 'description': 'This cohort includes adult patients undergoing isolated coronary artery bypass graft (CABG) surgery with extracorporeal circulation (ECC). Each participant is evaluated preoperatively for cardiovascular autonomic neuropathy (CAN) using the Valsalva maneuver, sitting-to-standing test, and cold/heat test. Demographic, hemodynamic, and laboratory data, as well as regional cerebral oxygen saturation (rSO₂), are recorded. Postoperative outcomes include acute kidney injury (AKI) assessed by KDIGO criteria, complications, ICU and hospital stay, and mortality. No intervention is applied.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07050', 'city': 'Antalya', 'state': 'Antalya', 'country': 'Turkey (Türkiye)', 'facility': 'Akdeniz University, Faculty of Medicine, Department of Anesthesiology and Reanimation', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared. The data will be used solely for the purposes of this study."'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akdeniz University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Anesthesiology, Akdeniz University, Antalya, Turkey', 'investigatorFullName': 'Emel Gunduz', 'investigatorAffiliation': 'Akdeniz University'}}}}