The Immunoadsorption Effect of Arterio-venous ECMO in Refractory Septic Shock With ARDS Following Severe Lung Contusion
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- number of patients weaned from ventilators
研究概览
简要总结
To evaluate and compare the effect of immunoadsorption effect of A-V ECMO on course of sepsis weaning from inotropes, weaning from the ventilator, duration of ICU stays and effect on mortality rate in patients with septic shock and respiratory failure due to ARDS followed severe lung contusion.
详细描述
100 patients with respiratory failure without improvement after 10 days ventilation due to development of VAP with ARDS, had >2 SOFA score and >6 CPIS score included in two groups 50 patients in each. Only patients of group B put on A-V ECMO while patients of group A continue on traditional way of management. Improvement of ARDS &VAP, weaning from ventilation, duration of ICU stays, improvement of one/all parameters of both SOFA and CPIS scores, morbidity and mortality recorded and compared within 14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those who had an age between 18-65 years old
- •patients ventilated for more than 10 days
- •with conscious level more than 8/15 on Glasgow Coma Scale
排除标准
- •pediatric patients below 18 years of age
研究组 & 干预措施
Group A
Group A continue on the same conventional way of management as mentioned above with conventional way of ventilation and broad spectrum antibiotics coverage
干预措施: Meropenem Injection (Drug)
Group B
group B who connected to (A-VECMO).with venous access from femoral vien and arterial cannulation using the femoral artery
干预措施: Meropenem Injection (Drug)
Group B
group B who connected to (A-VECMO).with venous access from femoral vien and arterial cannulation using the femoral artery
干预措施: A-V ECMO (Device)
结局指标
主要结局
number of patients weaned from ventilators
时间窗: 2 weeks
who showed improvement in CPIS score
number of patients disharged from ICU
时间窗: 2 weeks
who successfully weaned from the ventilator and complete 24 hours observation without symptoms
次要结局
未报告次要终点
研究者
Mohamed Gaber Allam
Consultant intensivist
King Abdul Aziz Specialist Hospital