Transcutaneous Auricular Vagus Nerve Stimulation as Adjuvant Treatment for Sepsis Patients

NCT07051694 | Recruiting

• 1 other identifier: AIIT2024050
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Keywords

sepsis; transcutaneous auricular vagus nerve stimulation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Day 8

Secondary Outcomes (6)

• blood

  Baseline and Day 8

• Glasgow coma scale

  Baseline and Day 8

• tidal volume

  Baseline and Day 8

• vasoactive-intropic score

  Baseline and Day 8

• Arterial blood gas (ABG) analysis

  Baseline and Day 8

Study Arms (2)

taVNS group

EXPERIMENTAL

transcutaneous auricular vagus nerve stimulation twice a day for 7 consecutive days.

Device: taVNS

sham-taVNS group

SHAM COMPARATOR

sham transcutaneous auricular vagus nerve stimulation twice a day for 7 consecutive days.

Device: sham-taVNS

Interventions

taVNS DEVICE

Transcutaneous Auricular Vagus Nerve Stimulation

taVNS group

sham-taVNS DEVICE

sham transcutaneous auricular vagus nerve stimulation

sham-taVNS group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Army Medical University

Chongqing, China

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hong Yang, PhD

CONTACT

+8618580262250; YHeasun@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: July 4, 2025
• Study Start: February 27, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: 1year after publishing this research paper
• Access Criteria: anyone who are intrested in this research

Locations

CN (1)