Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 340
- 试验地点
- 16
- 主要终点
- Reduction of the mortality rate of ARDS patients at d90
研究概览
简要总结
The use of neuromuscular blocking agents (NMBA) in ARDS patients has not been extensively investigated. The aim of the study is to show a reduction of the mortality rate of ARDS patients.
详细描述
The use of neuromuscular blocking agents (NMBA) in ARDS patients has not been extensively investigated. It has been recently demonstrated that a systematic 48-h infusion of NMBA is associated with a significant improvement in oxygenation as compared with a control group (Gainnier et al., Crit Care Med 2004). Moreover, a trend towards a reduction in the mortality rate has been observed. The aim of the study is to show a reduction of the mortality rate of ARDS patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ARDS with a PaO2 / FiO2 < 150 with a PEEP > 5 since less than 48 hrs
- •informed consent
排除标准
- •NMBA allergy
- •Continuous administration of NMBA for ARDS prior inclusion
- •Age < 18 yrs
- •SAPS II > 70
- •Persistent air leak
研究组 & 干预措施
A
干预措施: Placebo (Drug)
B
干预措施: cisatracurium (Drug)
B
干预措施: Cisatracurium besilate (Drug)
结局指标
主要结局
Reduction of the mortality rate of ARDS patients at d90
时间窗: 36 months
次要结局
- Mortality at day 28, day 60, day 180 and ICU mortality, Ventilator-free days and alive at day 28 and day 60, Exposure time to FIO2 > 80% or PEEP > 10 cmH2O during the first 7 days, Sedatives and analgesics requirements during the first 7 days(march 2009)
- Organ failure-free days and alive at day 28, Incidence of barotrauma, Incidence of critical illness neuromyopathy, Incidence of ventilator-associated pneumonia, Quality of life at day 180(march 2009)