Effects of Cardiovascular Autonomic Neuropathy (CAN) on Acute Kidney Injury and Clinical Outcomes in Patients Undergoing Isolated Coronary Artery Bypass Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 912
- 试验地点
- 1
- 主要终点
- Incidence of Acute Kidney Injury (AKI)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older
- •Scheduled for elective isolated Coronary Artery Bypass Graft (CABG) surgery with planned extracorporeal circulation (ECC)
- •Provide informed consent
排除标准
- •Emergency or revision CABG surgeries
- •Chronic kidney failure or dialysis
- •Severe chronic respiratory disease (COPD, asthma, chronic bronchitis) affecting test reliability
- •Uncontrolled hypertension
- •Use of antiarrhythmic drugs affecting heart rate-based autonomic tests
- •Orthopedic or neurological conditions preventing standing tests
研究组 & 干预措施
CABG Surgery Cohort
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.
结局指标
主要结局
Incidence of Acute Kidney Injury (AKI)
时间窗: Postoperative 7 days
AKI will be assessed according to KDIGO criteria using serum creatinine, BUN, GFR values, and urine output within the first 7 days postoperatively.
次要结局
未报告次要终点
研究者
Emel Gunduz
Associate Professor of Anesthesiology, Akdeniz University, Antalya, Turkey
Akdeniz University