Transcutaneous Auricular Vagus Nerve Stimulation as Adjuvant Treatment for Sepsis Patients
NCT ID: NCT07051694
Last Updated: 2025-07-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-02-27
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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taVNS group
transcutaneous auricular vagus nerve stimulation twice a day for 7 consecutive days.
taVNS
Transcutaneous Auricular Vagus Nerve Stimulation
sham-taVNS group
sham transcutaneous auricular vagus nerve stimulation twice a day for 7 consecutive days.
sham-taVNS
sham transcutaneous auricular vagus nerve stimulation
Interventions
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taVNS
Transcutaneous Auricular Vagus Nerve Stimulation
sham-taVNS
sham transcutaneous auricular vagus nerve stimulation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
80 Years
ALL
No
Sponsors
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Third Military Medical University
OTHER
Responsible Party
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Tan Liang
Clinical Professor
Locations
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The First Affiliated Hospital of Army Medical University
Chongqing, , China
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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AIIT2024050
Identifier Type: -
Identifier Source: org_study_id
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