Clinical Trial

Transcutaneous Auricular Vagus Nerve Stimulation for Preventing Acute Kidney Injury in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass

Enrolling by Invitation
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Summary
Acute kidney injury (AKI) is a common complication after cardiac surgery using cardiopulmonary bypass, leading to longer hospital stays and worse outcomes. Effective preventive therapies are lacking. This randomized controlled trial investigates whether transcutaneous auricular vagus nerve stimulation (taVNS)-a non-invasive ear stimulation technique-can reduce AKI after cardiac surgery. A total of 152 patients undergoing elective cardiac surgery with cardiopulmonary bypass will be randomly assigned to receive either taVNS or sham stimulation. The intervention begins before surgery and continues daily through postoperative day 5. The primary outcome is the incidence of AKI within 7 days after surgery. Secondary outcomes include AKI severity, need for dialysis, kidney function recovery, complications, and inflammatory biomarkers. This study is approved by the institutional ethics committee. All participants will provide written informed consent.
Protocol Amendment History 2 changes
critical Trial status changed: Not Yet Recruiting → Enrolling by Invitation 2026-05-23
notable Primary completion moved earlier: 2027-04-01 -> 2026-12-31 2026-05-23
Trial Details
NCT Number NCT07549243
Lead Sponsor Sir Run Run Shaw Hospital
Conditions Acute Kidney Injury, Cardiac Surgery, Cardiopulmonary Bypass
Enrollment 152 participants
Start Date 2026-04-27
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-05-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-22