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Recruiting NCT07051694

Transcutaneous Auricular Vagus Nerve Stimulation as Adjuvant Treatment for Sepsis Patients

No phase Interventional Sepsis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: taVNS, sham-taVNS.
Who it may be relevant to
Registry conditions: Sepsis. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • Device taVNS
    Transcutaneous Auricular Vagus Nerve Stimulation
  • Device sham-taVNS
    sham transcutaneous auricular vagus nerve stimulation

Primary outcome measures

  • SOFA socre [Time frame: Baseline and Day 8]
Secondary outcome measures (6)
  • blood [Time frame: Baseline and Day 8]
  • Glasgow coma scale [Time frame: Baseline and Day 8]
  • tidal volume [Time frame: Baseline and Day 8]
  • vasoactive-intropic score [Time frame: Baseline and Day 8]
  • Arterial blood gas (ABG) analysis [Time frame: Baseline and Day 8]
  • fraction of inspiration O2 [Time frame: Baseline and Day 8]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of Army Medical University — Chongqing

Identifiers

NCT: NCT07051694 · AIIT2024050

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗