Transcutaneous auricular vagus nerve stimulation to prevent kidney injury after heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, sham-controlled study enrolls 152 adults undergoing elective cardiac surgery with cardiopulmonary bypass to test if taVNS started before surgery and continued for 5 postoperative days can reduce the occurrence of acute kidney injury. Participants are assigned to active taVNS or sham stimulation, with the primary outcome being AKI within 7 days after surgery. Secondary outcomes include AKI severity, dialysis need, kidney function recovery, perioperative complications, and inflammatory biomarkers. The trial is conducted with ethics approval and informed consent, at Sir Run Run Shaw Hospital in China, with no disclosed collaborators beyond the lead site.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years
* Scheduled for elective cardiac surgery with cardiopulmonary bypass under general anesthesia
* Baseline estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m² (CKD-EPI formula)
* American Society of Anesthesiologists (ASA) physical status classification I-III
* New York Heart Association (NYHA) functional classification I-III
* Able to understand and cooperate with study procedures
* Willing to participate and provide written informed consent. For participants unable to read or sign due to incapacity or illiteracy, consent may be obtained from a legally authorized representative or witnessed by an impartial third party as per ethical guidelines

Exclusion Criteria:

* Solitary kidney, history of kidney transplantation, pre-existing renal replacement therapy, or pre-existing acute kidney injury (KDIGO criteria)
* Contraindications to transcutaneous auricular vagus nerve stimulation, including active infection, dermatitis, skin breakdown, or severe psoriasis in the bilateral auricular region; allergy to silicone, electrode gel, or device materials; uncontrolled arrhythmia, symptomatic bradycardia, sick sinus syndrome, second- or third-degree atrioventricular block, implanted pacemaker or defibrillator; carotid sinus hypersensitivity; uncontrolled epilepsy; or active peptic ulcer disease
* Received vagus nerve stimulation, auricular acupuncture, or transcutaneous electrical nerve stimulation within 1 month prior to enrollment
* Long-term use of medications that significantly affect autonomic nervous system tone or renal blood flow and cannot be safely paused before surgery
* Active systemic infection or sepsis (Sepsis-3 criteria) prior to surgery
* Acute ischemic or hemorrhagic stroke, or acute myocardial infarction within 3 months prior to enrollment
* Severe hepatic dysfunction (Child-Pugh Class C), acute liver failure, or other serious life-threatening conditions
* Vulnerable populations (excluding elderly or illiterate individuals) including critically ill patients, individuals with psychiatric disorders, cognitive impairment, or pregnant women
* Any other condition deemed by the investigator to make the participant unsuitable for study participation

Where it's running

• Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
  Hangzhou, Zhejiang, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.