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Effect of Perioperative Repeated Transcutaneous Auricular Vagus Nerve Stimulation on Cardiac Surgery-Associated Acute Kidney Injury: A Randomized Controlled Trial

Effect of Perioperative Repeated Transcutaneous Auricular Vagus Nerve Stimulation on Cardiac Surgery-Associated Acute Kidney Injury: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114755
Enrollment
Unknown
Registered
2025-12-17
Start date
2025-12-22
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery-Associated Acute Kidney Injury

Interventions

Active Group:1. Stimulation method: The left auricular concha is selected as the stimulation site. The left external auditory canal and conchal area are first cleaned with an alcohol swab, after which
current intensity 1–3 mA (adjusted according to patient tolerance)
duty cycle 100%. 3. Stimulation protocol: After the initiation of cardiopulmonary bypass, taVNS is applied for 30 minutes. On the day of surgery, an additional 20-minute stimulation is administered af
Sham Group:1. Sham stimulation method: The left auricular concha is selected as the stimulation site. The left external auditory canal and conchal area are first cleaned with an alcohol swab, after wh

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years; 2. Scheduled to undergo elective cardiac surgery with cardiopulmonary bypass, with an expected cardiopulmonary bypass duration of more than 90 minutes; 3.Willing and able to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients undergoing emergency surgery; 2. Chronic kidney disease (CKD) stage 4 or higher (eGFR 10 mg/day prednisone or equivalent); 5.Severe ear disease (e.g., auricular infection, auricular malformation) preventing proper electrode placement or posing a risk of local injury; 6. Severe neurological disease or documented vagus nerve injury; 7.Severe gastrointestinal disease; 8.Pre-existing asthma before surgery; 9. Pre-existing epilepsy before surgery; 10.Presence of an implanted cardiac pacemaker, cochlear implant, or other electronic implantable device; 11.Preoperative severe cardiac arrhythmias, such as high-grade atrioventricular block or sick sinus syndrome; 12.Infective endocarditis; 13.Refusal or inability to provide written informed consent; 14. Deemed unsuitable for inclusion in this study at the discretion of the investigators.

Design outcomes

Primary

MeasureTime frame
Incidence of CSA-AKI;

Secondary

MeasureTime frame
Urine output;Serum creatinine level;Incidence of postoperative kidney replacement therapy (KRT);Levels of inflammatory cytokines (IL-2IL-6 IL-8IL-10IFN-?TNFCRP);B-type natriuretic peptide;CTnI;Lac;Sequential Organ Failure Assessment;Acute physiology and chronic Health Evaluation II;Duration of postoperative invasive mechanical ventilation;ICU length of stay;Hospital length of stay;All-cause mortality within 30 days after surgery;All-cause mortality within 90 days after surgery;Standard Deviation of Normal-to-Normal RR intervals;24h Averaged Root Mean Square of Successive Differences;NT-proBNP;

Countries

China

Contacts

Public ContactZhang Chengxin

The First Affiliated Hospital of Anhui Medical University

zhangchengxin@ahmu.edu.cn+86 551 6590 8740

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026