A Multicenter Clinical Study on the Effect of Electroacupuncture on the Mechanical Ventilation Strategy in Patients With Sepsis-related ARDS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Respiratory mechanics indicators 3
研究概览
简要总结
In order to clarify the clinical efficacy of electroacupuncture on inhibiting systemic inflammatory response, improving respiratory mechanics parameters and prognosis in patients with sepsis-related 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 (Investigator)
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
- •Meet the diagnostic criteria of the Surviving Sepsis Campaign: Updated International Guidelines for the Treatment of Sepsis and Septic Shock 2021
- •Meet the diagnostic criteria of the European Society of Critical Care Medicine (ESICM) Guidelines for Acute Respiratory Distress Syndrome: Definition, Phenotype and Respiratory Support Strategies
- •Age >18 years
- •Expected duration of mechanical ventilation>48 hours
- •Expected ICU stay of more than 7 days
- •Signed informed consent.
排除标准
- •Participated in other clinical trials
- •Pregnant, lactating or miscarriage
- •Patients with disseminated tumors or tumors receiving chemotherapy and other special treatments
- •Alcohol abuse
- •Severe cardiovascular, brain, liver, kidney, psychiatric diseases, diabetes, multiple system atrophy, cauda equina injury or myelopathy
- •Systolic blood pressure < 90mmHg within 2 hours before the start of the study
- •Severe burns or severe skin diseases
- •Pacemaker placement, metal allergy or severe needle sickness
- •Abnormal coagulation function
结局指标
主要结局
Respiratory mechanics indicators 3
时间窗: Day 0、day 7
Driving pressure(DP)
Respiratory mechanics indicators 2
时间窗: Day 0、day 7
Respiratory rate(RR)
Respiratory mechanics indicators 1
时间窗: Day 0、day 7
Oxygenation index(P/F)
Respiratory mechanics indicators 4
时间窗: Day 0、day 7
Positive end expiratory pressure(PEEP)
Respiratory mechanics indicators 5
时间窗: Day 0、day 7
Mechanical ventilation days(MV days)
Respiratory mechanics indicators 6
时间窗: Day 0、day 7
Mechanical ventilation free days(MV free days)
Respiratory mechanics indicators 7
时间窗: Day 0、day 7
Extubation situation
次要结局
- ECMO applications(Day 0 to day 7)
- Sedation and analgesia(Day 0、day 7)
- Analgesic drug use(Day 0、day 7)
- Inflammatory factors(Day 0、day 7)
- All-cause mortality to day 28(Up to 28 days)
- All-cause mortality to day 60(Up to 60 days)
- Vasoactive drugs applications(Day 0 to day 7)
- CRRT applications(Day 0 to day 7)
- ICU-free days(2 year)
- Hospital-free days(2 year)
- CD4、CD8、CD4/CD8(Day 0、day 7)
- Sedative drug use(Day 0、day 7)
研究者
Jun Lu, MD
Director
Nanjing University of Traditional Chinese Medicine