RecruitingNot ApplicableNCT07051694

Transcutaneous Auricular Vagus Nerve Stimulation as Adjuvant Treatment for Sepsis Patients

Exploratory Study on Transcutaneous Auricular Vagus Nerve Stimulation as Adjuvant Treatment for Sepsis Patients

Sponsor

Third Military Medical University

Enrollment

60 participants

Start Date

Feb 27, 2025

Study Type

INTERVENTIONAL

Conditions

Sepsis

Summary

The goals of this randomized clinical trial are to investigate the effects of transcutaneous auricular vagus nerve stimulation (taVNS) combined with standard intensive care on systemic organ function in septic patients, and exploring its potential mechanisms for improving overall outcomes in sepsis.The main question it aims to answer is whether taVNS can reduce the severity of sepsis patients by ameliorating systemic inflammation.Participants will receive standard intensive care treatment and be randomized to receive the taVNS or sham taVNS as adjuvant treatment twice a day for 7 consecutive days. Several evaluations will be done before and after the intervention.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

Age 18-80
Sepsis was diagnosed per the Sepsis-3 criteria (SCCM/ESICM 2016) as infection with SOFA score ≥ 2
ICU admission within 7 days after sepsis onset
Informed consent was obtained from patients/guardians

Exclusion Criteria10

severe ARDS defined by PaO₂/FiO₂ ≤100 mmHg with PEEP ≥5 cm H₂O
HR>120 per minute
epinephrine or norepinephrine >1ug/kg/min
severe underlying pulmonary diseases including interstitial lung disease, -
diffuse alveolar hemorrhage, severe asthma, or lung cancer
taVNS contraindications: existing pacemakers, cochlear implants, or other active implantable electronic medical devices
dermatologic or infectious disorders affecting the auricular region
pregnancy or lactation
participation in other clinical trials
inability to remain motionless during treatment (e.g., due to epilepsy or Parkinson's disease)