Effect of Cardiovascular Autonomic Neuropathy on AKI and Outcomes in Isolated CABG Surgery

NCT07254468 | Completed

• 1 other identifier: CAN_AKI_STUDY
• Study Type: observational
• Target: 912
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury (AKI); Coronary Artery Bypass Graft (CABG); Postoperative Outcomes; Cardiovascular Autonomic Neuropathy (CAN)

Keywords

Cardiovascular Autonomic Neuropathy (CAN); Acute Kidney Injury (AKI); Coronary Artery Bypass Graft (CABG)

Outcome Measures

Primary Outcomes (1)

• Incidence of Acute Kidney Injury (AKI)

  AKI will be assessed according to KDIGO criteria using serum creatinine, BUN, GFR values, and urine output within the first 7 days postoperatively.

  Postoperative 7 days

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Adults aged 18 years or older
• Scheduled for elective isolated Coronary Artery Bypass Graft (CABG) surgery with planned extracorporeal circulation (ECC)
• Provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University, Faculty of Medicine, Department of Anesthesiology and Reanimation

Antalya, Antalya, 07050, Turkey (Türkiye)

Location

Related Links

• Systematic review on the association between diabetic peripheral neuropathy and cardiac autonomic neuropathy.

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology, Akdeniz University, Antalya, Turkey

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 28, 2025
• Study Start: November 4, 2021
• Primary Completion: January 10, 2025
• Study Completion: March 10, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)