Transcutaneous Auricular Vagus Nerve Stimulation as Adjuvant Treatment for Sepsis Patients

Not Applicable

Recruiting

• Conditions: Sepsis

• Registration Number: NCT07051694
• Lead Sponsor: Third Military Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-27
• Status Verified: 2025-06
• Study First Submitted: 2025-06-03
• Study First Submitted QC: 2025-06-30
• Last Update Submitted: 2025-06-30
• Study First Posted: 2025-07-04
• Last Update Posted: 2025-07-04
• Primary Completion: 2026-10-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
SOFA socre	Baseline and Day 8	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.

Secondary Outcome Measures

Name	Time	Method
blood	Baseline and Day 8	Routine complete blood count
Glasgow coma scale	Baseline and Day 8	pecific scoring criteria were established for eye opening, verbal response, and motor response, with maximum scores of 4, 5, and 6 points respectively. A higher score indicating better condition.
tidal volume	Baseline and Day 8	tested by mechanical ventilation
vasoactive-intropic score	Baseline and Day 8	VIS can intuitively reflect the degree of dependence of sepsis patients on vasoactive drugs, providing a quantitative indicator for clinicians. It helps to more accurately assess the condition of sepsis, evaluate the therapeutic effect and predict the prognosis. The larger the value, the more severe the condition.
Arterial blood gas (ABG) analysis	Baseline and Day 8	Arterial blood gas (ABG) analysis
fraction of inspiration O2	Baseline and Day 8	tested by mechanical ventilation

Trial Locations

Locations (1)

The First Affiliated Hospital of Army Medical University; 🇨🇳 Chongqing, China