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:
Akdeniz University
Organization:
Study Overview
Official Title:
Effects of Cardiovascular Autonomic Neuropathy (CAN) on Acute Kidney Injury and Clinical Outcomes in Patients Undergoing Isolated Coronary Artery Bypass Surgery
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAN-AKI-CABG
Brief Summary:
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).
Preoperative 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.
Postoperatively, 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.
The 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.
This 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.
Preoperative 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.
Postoperatively, 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.
The 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.
This 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.
Detailed Description:
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.
Study Population:
Adults aged 18 years or older scheduled for elective isolated CABG surgery with planned ECC.
Inclusion Criteria:
Elective isolated CABG surgery Age ≥18 years
Exclusion Criteria:
Emergency or revision surgeries
Orthopedic conditions preventing standing tests
Chronic respiratory diseases affecting test reliability (COPD, asthma, chronic bronchitis)
Uncontrolled hypertension
Use of antiarrhythmic drugs affecting heart rate-based tests
Chronic kidney failure
Preoperative Assessment:
CAN diagnosis using Valsalva maneuver, sitting-to-standing test, and cold/heat test (positive if ≥2 tests are abnormal).
Collection of demographic data, comorbidities, laboratory tests (BUN, creatinine, GFR, ), hemodynamic parameters, and baseline regional cerebral oxygen saturation (rSO2).
Intraoperative Monitoring:
Hemodynamic parameters, urine output, blood gases, cardiopulmonary bypass and aortic cross-clamp times, and number of coronary anastomoses recorded.
Regional cerebral oxygen saturation (rSO2) continuously monitored during ECC, with values recorded for analysis but not used for clinical decisions.
Mean arterial pressure maintained at 60-100 mmHg; crystalloids infused at ≥100 ml/h; ephedrine administered if MAP \<60 mmHg.
Postoperative Evaluation:
Kidney function monitored at 24h, 48h, and 7 days postoperatively using KDIGO criteria.
Evaluation of neurological outcomes, mechanical ventilation duration, inotropic support, transfusion requirements, postoperative complications (reoperation, mediastinitis, myocardial infarction), ICU and hospital length of stay, and mortality.
Study Objectives:
Primary: Assess the effect of CAN on AKI incidence.
Secondary: Evaluate CAN's impact on other clinical outcomes
Ethics and Compliance:
Approved by Acıbadem University and Acıbadem Healthcare Institutions Medical Research Ethics Committee (ATADEK), approval number 2020-21/13.
Conducted according to ethical principles and Good Clinical Practice (GCP) standards.
Study Population:
Adults aged 18 years or older scheduled for elective isolated CABG surgery with planned ECC.
Inclusion Criteria:
Elective isolated CABG surgery Age ≥18 years
Exclusion Criteria:
Emergency or revision surgeries
Orthopedic conditions preventing standing tests
Chronic respiratory diseases affecting test reliability (COPD, asthma, chronic bronchitis)
Uncontrolled hypertension
Use of antiarrhythmic drugs affecting heart rate-based tests
Chronic kidney failure
Preoperative Assessment:
CAN diagnosis using Valsalva maneuver, sitting-to-standing test, and cold/heat test (positive if ≥2 tests are abnormal).
Collection of demographic data, comorbidities, laboratory tests (BUN, creatinine, GFR, ), hemodynamic parameters, and baseline regional cerebral oxygen saturation (rSO2).
Intraoperative Monitoring:
Hemodynamic parameters, urine output, blood gases, cardiopulmonary bypass and aortic cross-clamp times, and number of coronary anastomoses recorded.
Regional cerebral oxygen saturation (rSO2) continuously monitored during ECC, with values recorded for analysis but not used for clinical decisions.
Mean arterial pressure maintained at 60-100 mmHg; crystalloids infused at ≥100 ml/h; ephedrine administered if MAP \<60 mmHg.
Postoperative Evaluation:
Kidney function monitored at 24h, 48h, and 7 days postoperatively using KDIGO criteria.
Evaluation of neurological outcomes, mechanical ventilation duration, inotropic support, transfusion requirements, postoperative complications (reoperation, mediastinitis, myocardial infarction), ICU and hospital length of stay, and mortality.
Study Objectives:
Primary: Assess the effect of CAN on AKI incidence.
Secondary: Evaluate CAN's impact on other clinical outcomes
Ethics and Compliance:
Approved by Acıbadem University and Acıbadem Healthcare Institutions Medical Research Ethics Committee (ATADEK), approval number 2020-21/13.
Conducted according to ethical principles and Good Clinical Practice (GCP) standards.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: