Transcutaneous Auricular Vagus Nerve Stimulation as Adjuvant Treatment for Sepsis Patients

Third Military Medical University60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Sepsis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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)

Outcomes

Primary Outcomes

SOFA socre

The total SOFA score is obtained by adding the scores of the six systems: respiratory, coagulation, liver, cardiovascular, central nervous, and renal. The SOFA score ranges from 0 to 24, with a higher score indicating more severe organ dysfunction.