Exploratory Study on Transcutaneous Auricular Vagus Nerve Stimulation as Adjuvant Treatment for Sepsis Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- SOFA socre
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
taVNS group
transcutaneous auricular vagus nerve stimulation twice a day for 7 consecutive days.
干预措施: taVNS (Device)
sham-taVNS group
sham transcutaneous auricular vagus nerve stimulation twice a day for 7 consecutive days.
干预措施: sham-taVNS (Device)
结局指标
主要结局
SOFA socre
时间窗: 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.
次要结局
- 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)
- fraction of inspiration O2(Baseline and Day 8)
研究者
Tan Liang
Clinical Professor
Third Military Medical University