Electroacupuncture Modulates the Metabolism of SPMs and Ameliorates Respiratory Symptoms and Inflammation in Patients With Sepsis Complicating ARDS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Serum levels of Lipoxin A4 (LXA4)
研究概览
简要总结
In this interventional clinical trial, researchers will administer electroacupuncture versus sham electroacupuncture to sepsis patients with ARDS and collect objective outcome measures. The study will be divided into 2 groups. The EA group will receive electroacupuncture and the SHAM-EA group will receive sham electroacupuncture. The purpose of this study is to investigate the effect of electroacupuncture on the synthesis of SPMs in sepsis patients with ARDS.
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
- Single (Care Provider)
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
- •Males or females over the age of 18;
- •Diagnosis meets SPESIS 3 criteria for sepsis;
- •The diagnosis meets the Berlin diagnostic criteria for ARDS;
- •ARDS was diagnosed within 48h;
- •Capable of understanding the purpose and risk of the study;
- •Patients or proxy must give written informed consent before any assessment is performed.
排除标准
- •ARDS was diagnosed 48h later;
- •Pregnancy, lactation or perinatal period;
- •malignant tumor;
- •Severe liver failure or kidney failure;
- •Predicted mortality risk of patients within 24h>80%;
- •Severe end-stage lung disease;
- •ECMO patients are undergoing implementation;
- •HIV seropositive or Syphilis seropositive;
- •Any clinical-relevant condition that might affect study participation and/or study results;
- •Participation in any other intervention trial;
- •Unwillingness or inability to following the study protocol in the investigators opinion.
研究组 & 干预措施
Electroacupuncture (EA)
The acupoints were "Deqi", and the electroacupuncture stimulator was connected and energized.
干预措施: electroacupuncture treatment (Device)
Sham electroacupuncture (SHAM-EA)
No "Deqi" operation was performed on non-acupuncture points, and the electroacupuncture stimulator was connected and not energized.
干预措施: sham electroacupuncture treatment (Device)
结局指标
主要结局
Serum levels of Lipoxin A4 (LXA4)
时间窗: Up to 7 days
Serum levels of LXA4 were measured in post-intervention patients and levels were compared to Day 0.
次要结局
- plateau pressure(Up to 7 days)
- Oxygenation index(Up to 7 days)
- Sequential Organ-Failure Assessment (SOFA) score(Up to 7 days)
- LXA4 levels in BALF(Up to 7 days)
- Ventilation-free days(Up to 28 days)
- Inflammation biomarkers Inflammation levels(Up to 7 days)
- Ventilator-provided positive end-expiratory pressure (PEEP)(Up to 7 days)
- tidal volume(Up to 7 days)
- Rate of electroacupuncture-related adverse events(Up to 28 days)
研究者
Jianbo Yu
Prof.
Tianjin Nankai Hospital