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

Официальное название

Transcutaneous Auricular Vagus Nerve Stimulation for Preventing Acute Kidney Injury in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass: A Randomized Controlled Trial

Обзор

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.

Вмешательства

• Устройство Transcutaneous Auricular Vagus Nerve Stimulation
  Participants in this arm receive active transcutaneous auricular vagus nerve stimulation (ta-VNS) using the tVNS501 device. Stimulation is delivered to the left cymba conchae (auricular branch of the vagus nerve) with the following parameters: frequency 25 Hz, pulse width 250 µs, 30 seconds on / 30 seconds off cycling. Intensity is adjusted starting from 0.4 V and increased in 0.4 V increments until the participant perceives mild discomfort, then reduced to the highest tolerable non-painful leve
• Устройство Sham Stimulation
  Participants in this arm receive sham stimulation using the same tVNS501 device. Electrodes are placed on the left cymba conchae following the same procedure as the active group, but no electrical current is delivered. The stimulation settings are displayed on the device to maintain blinding, but the output is turned off. The schedule and duration of device application are identical to those in the active stimulation group.

Первичные конечные точки

• Incidence of Acute Kidney Injury (AKI) Within 7 Days After Surgery [Срок оценки: Within 7 days after surgery]

Вторичные конечные точки (12)

• Severity of Acute Kidney Injury (AKI) by KDIGO Stage [Срок оценки: Within 7 days after surgery]
• Requirement of Renal Replacement Therapy (RRT) [Срок оценки: From surgery to hospital discharge, assessed daily, up to 90 days]
• Duration of RRT [Срок оценки: From initiation to discontinuation of RRT, assessed daily, up to 90 days]
• Persistent AKI at Postoperative Day 7 [Срок оценки: Postoperative day 7]
• Time to Kidney Function Recovery Among Participants With AKI [Срок оценки: From AKI diagnosis to recovery, assessed daily, up to 30 days after surgery]
• Serum Creatinine Level at 30 Days After Surgery [Срок оценки: At postoperative day 30]
• Estimated Glomerular Filtration Rate (eGFR) at 30 Days Post-Surgery [Срок оценки: At postoperative day 30]
• Duration of Mechanical Ventilation [Срок оценки: From the end of surgery until the time of first successful extubation, assessed up to 30 days.]
• Vasoactive-Inotropic Score (VIS) - Peak and Mean Values [Срок оценки: Within the first 7 postoperative days, assessed daily]
• Incidence of Postoperative Delirium Within 7 Days After Surgery [Срок оценки: Daily from postoperative day 1 through day 7]
• Change in Mini-Mental State Examination (MMSE) Score From Baseline [Срок оценки: Preoperative day 1, postoperative day 3, and postoperative day 7]
• Sleep Quality Assessed by Richards-Campbell Sleep Questionnaire (RCSQ) [Срок оценки: Preoperative day 1 (baseline), postoperative day 1 morning (assessing night of surgery), and postoperative day 3 morning (assessing night of day 2)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University — Ханчжоу

Идентификаторы

NCT: NCT07549243 · 20260315122240876

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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