The First Affiliated Hospital of Army Medical University
Chongqing, China
Location status: Recruiting
Recruiting
NCT Number: NCT07051694
Transcutaneous Auricular Vagus Nerve Stimulation as Adjuvant Treatment for Sepsis Patients
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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)
Treatment and study plan
taVNS
DeviceTranscutaneous Auricular Vagus Nerve Stimulation
sham-taVNS
Devicesham transcutaneous auricular vagus nerve stimulation
Primary outcomes
-
SOFA socre
Time frame: 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 outcomes
-
blood
Time frame: Baseline and Day 8
Routine complete blood count
-
Glasgow coma scale
Time frame: 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
Time frame: Baseline and Day 8
tested by mechanical ventilation
-
vasoactive-intropic score
Time frame: 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
Time frame: Baseline and Day 8
Arterial blood gas (ABG) analysis
-
fraction of inspiration O2
Time frame: Baseline and Day 8
tested by mechanical ventilation
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Third Military Medical University
Other
Registry information
Official study title
Exploratory Study on Transcutaneous Auricular Vagus Nerve Stimulation as Adjuvant Treatment for Sepsis Patients
Acronym: TaVNS-Sepsis
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jul 4, 2025
- Registry last updated
- Jul 4, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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