acute kidney injury
Conditions
Interventions
Percutaneous Auricular Vagus Stimulation Group:Percutaneous Auricular Vagus Stimulation
Sponsors
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2. Scheduled to undergo elective cardiac surgery with cardiopulmonary bypass (CPB) under general anesthesia. 3. Baseline estimated glomerular filtration rate (eGFR) calculated from serum creatinine >= 60 mL/min/1.73 m². 4. American Society of Anesthesiologists (ASA) physical status classification Grade I–III. 5. New York Heart Association (NYHA) cardiac functional classification Grade I–III. 6. Possess adequate comprehension and communication ability to comply with study procedures. 7. Voluntary participation in this study and provision of signed informed consent. If a participant is unable to read or sign the informed consent form due to lack of legal capacity or other reasons, a legal guardian shall provide informed consent on their behalf and sign the form. If a participant is unable to read the informed consent form (e.g., illiterate participants), an impartial witness shall witness the informed consent process and sign the form.
Exclusion criteria
Exclusion criteria: 1. Solitary kidney, history of kidney transplantation, preoperative renal replacement therapy (RRT), or preoperative acute kidney injury (AKI) defined by the KDIGO criteria. 2. Presence of contraindications to ta-VNS, including active infection, dermatitis, skin lesions, or severe psoriasis in the bilateral auricular stimulation areas; allergy to materials of stimulation devices such as silica gel or electrode gel; concomitant uncontrolled arrhythmia, symptomatic bradycardia, sick sinus syndrome, atrioventricular block of second degree or higher, implanted cardiac pacemaker or defibrillator, carotid sinus hypersensitivity, uncontrolled epilepsy, or active peptic ulcer. 3. Received vagus nerve stimulation, auricular acupuncture, or transcutaneous electrical nerve stimulation within 1 month before enrollment. 4. Long-term use of medications that significantly affect autonomic tone or renal blood flow and cannot be safely discontinued preoperatively. 5. Preoperative active systemic infection or sepsis (according to Sepsis-3 criteria). 6. Acute ischemic stroke, hemorrhagic stroke, or acute myocardial infarction within 3 months before enrollment. 7. Severe hepatic insufficiency (Child-Pugh Class C), acute liver failure, or other severe comorbidities. 8. Vulnerable populations other than elderly or illiterate participants, including critically ill patients, individuals with psychiatric disorders, cognitive impairment, pregnant women, etc. 9. Any other conditions deemed by the investigators to render the participant unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of AKI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients requiring acute renal replacement therapy (RRT) and its duration.;Perioperative complications and mortality;Serum creatinine and eGFR at 30 days postoperatively;AKI Severity;Autonomic nervous function;Recovery of kidney function;Biomarkers;Length of hospital stay, length of ICU stay, and rate of readmission due to complications.;Quality of recovery in the early postoperative period; | — |
Countries
China
Contacts
Public ContactGang Chen
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Outcome results
None listed