Efficacy and Safety Study of Early Electroacupuncture Treatment Combined With ICU Standard Therapy on Organ Dysfunction and Clinical Outcomes in Patients With Sepsis: a Single-center, Randomized, Sham-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 308
- 试验地点
- 1
- 主要终点
- Change in the SOFA score between baseline and 7 days after randomization
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of electroacupuncture (EA) combined with standard Intensive Care Unit (ICU) therapy on organ dysfunction and other clinical outcomes in sepsis patients. Additionally, this study will conduct subgroup analyses to investigate the influence of septic shock and immunomodulators on the treatment effects and their correlation with electroacupuncture efficacy.
详细描述
The proposed single-center, participant-blind, two arms, randomized, sham-controlled clinical trial is to evaluate the efficacy and safety of electroacupuncture (EA) combined with standard Intensive Care Unit (ICU) therapy on organ dysfunction and other clinical outcomes in sepsis patients. We planned to conduct this single-center trial in Tongji Hospital, affiliated to Huazhong University of Science and Technology (HUST). Patients, who are initially diagnosed with sepsis, will be assessed for eligibility within 24 hours of their ICU admission. Then, eligible participants will be informed and randomly assigned to one of the two groups: the EA group or the sham EA group, in a 1:1 ratio using block randomization. Patients will receive the first EA/sham EA therapy within 24 hours after randomization. The treatment will be administered once daily for 6 days continuously, and followed by 28 days after randomization. The primary outcome will be the SOFA score at Day 7 after randomization. Secondary outcomes include mortality, ICU-free days, hospital-free days, organ-support-free days at Day 28. SOFA score components and related serological results will also be included. Data collection will be conducted by an electronic data management system. Data analyses will be performed on a full analysis set and a per protocol set.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Statistician
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old, and gender is not limited.
- •Meets the diagnostic criteria of Sepsis (Sepsis-3): In patients with infection or suspected infection, Sepsis is diagnosed when the Sequential (Sepsis related) Organ Failure Assessment (SOFA) score increased by ≥2 points from baseline.
- •Patients or their legal representatives understand and voluntarily sign the informed consent for this study.
排除标准
- •Patients with lower extremity denervation.
- •Patients with lower extremity amputation or congenital disability with lower limb hypoplasia.
- •Patients with severe acute trauma such as active bleeding or unfixed fractures in the lower extremities.
- •Patients with skin damage, infection, bleeding, or hematoma near the lower extremity acupuncture site.
- •Patients with implantable medical devices, such as pacemakers, implantable cardioverter defibrillators (ICD) or deep brain stimulation (DBS).
- •Patients who are pregnant, breast feeding during the study.
- •Patients whose expected duration of ICU length of stay is less than 48 hours.
- •Patients whose legal representatives refuse routine active treatment and sign palliative treatment consent.
- •Patients who are currently participating in another randomized clinical trial.
- •Patients or their legal representatives refused to participate in the study or were unable to sign informed consent.
- •Immunosuppressive status, including but not limited to: congenital immunosuppressive patients, AIDS patients, organ transplant patients, long-term use of immunosuppressive patients, patients receiving tumor radiotherapy or chemotherapy within 1 month;
- •Patients with an anticipated survival prognosis of no more than 7 days due to advanced disease.
研究组 & 干预措施
EA group
For the EA group, participants will be assigned to receive 6 sessions of EA applied at bilateral acupoints Zusanli (ST36) and Yanglingquan (GB34), once daily, with the first session of EA applied within 24 hours after randomization.
干预措施: Electroacupuncture (Device)
Sham EA group
For the sham EA group, participants will be assigned to receive 6 sessions of sham EA on two sham points, once daily, with the first session of sham EA applied within 24 hours after randomization.
干预措施: Sham electroacupuncture (Device)
结局指标
主要结局
Change in the SOFA score between baseline and 7 days after randomization
时间窗: At baseline (before randomization), and every day after the first treatment to day 7 after randomization
The SOFA (Sequential Organ Failure Assessment) score was based on six different scores, one for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems each scored from 0 to 4 with an increasing score reflecting worsening organ dysfunction.
次要结局
- All-cause mortality at day 28(At day 28 after randomization)
- All-cause ICU mortality at day 28(At day 28 after randomization)
- ICU-free days to day 28(At day 28 after randomization)
- Hospital-free days to day 28(At day 28 after randomization)
- Ventilator-free time to day 28(At day 28 after randomization)
- SOFA score at Day 8 and 9 after randomization(At day 8 and 9 after randomization)
- SOFA score of each system(At baseline (before randomization), and every day after the first treatment to day 9 after randomization)
- Vasopressor-free days to day 28(At day 28 after randomization)
- CRRT-free days to day 28(At day 28 after randomization)
- SOFA score components(At baseline (before randomization), and every day after the first treatment to day 9 after randomization)
- Liquid equilibrium parameter(At baseline (before randomization), and every day after the first treatment to day 6 after randomization)
研究者
Shusheng Li
Professor
Tongji Hospital