Evaluation of the Effectiveness of Extracorporeal Methods for Removing Mediators of Systemic Inflammation in Patient With Multiple Organ Dysfunction Syndrome After Heart and Aortic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- CRP
研究概览
简要总结
The purpose of this study is to assess the effectiveness and the safety of extracorporeal methods for removing mediators of systemic inflammation in patients with multiple organ dysfunction syndrome after heart and aorta surgery.
详细描述
After being informed about the study and potential risk, all patients with multiple organ dysfunction syndrome after heart and aorta surgery with indications for extracorporeal removal of inflammatory mediators, giving written informed consent will be included in the study.
Patients will be randomized 1:1 ratio to 1. hemoperfusion cartridge for cytokine sorption in combination with an oXiris membrane and 2. oXiris membrane.
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
- None
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
- •multiple organ dysfunction;
- •SOFA equal to or more than 4;
- •CRP equal to or more than 100 ng / ml;
- •increase of IL6 by 5 times or more
排除标准
- •the impossibility to use heparin ( bleeding; heparin-induced thrombocytopenia)
结局指标
主要结局
CRP
时间窗: 24 hours from the beginning of the study
сhange of CRP after 24 hours from baseline value
IL6
时间窗: 24 hours from the beginning of the study
сhange of IL6 after 24 hours from baseline value
SOFA
时间窗: 24 hours from the beginning of the study
change of SOFA values after 24 hours from baseline value
次要结局
- time spent in intensive care unit(hospitalisation period, an average of 1 month)
- inpatient stay time(through study completion, an average of 2 months)
- extracorporeal therapy(hospitalisation period, an average of 1 month)
- renal function of RIFLE(through study completion, an average of 2 months)
- lethality(through study completion, an average of 2 months)
研究者
Aleksandr Eremenko
Clinical Professor
Petrovsky National Research Centre of Surgery