COMPACT (COMbining Plasma-filtration and Adsorption Clinical Trial): Efficacy and Safety of High Doses CPFA (Coupled Plasma Filtration Adsorption) for Septic Shock in the ICU
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 115
- 试验地点
- 26
- 主要终点
- Hospital Mortality
研究概览
简要总结
The study objective is to clarify whether the application of high doses CPFA (coupled plasma-filtration adsorption) in addition to the current clinical practice is able to reduce hospital mortality in septic shock patients in intensive care unit (ICU).
详细描述
Septic shock is a life-threatening clinical condition characterized by cardiovascular failure as a consequence of infection. Septic shock frequently causes multi-organ failure in the ICU. For this reason the extracorporeal therapies for the treatment of renal failure have become widespread in the ICU and, at the same time, new extracorporeal depurative techniques have been developed for the removal of inflammatory mediators. One of these techniques is CPFA (coupled plasma-filtration adsorption) that uses a sorbent once the separation between plasma and blood has been obtained with a plasma filter. The study objective is to clarify whether the application of high doses CPFA in addition to the current clinical practice is able to reduce hospital mortality in septic shock patients in intensive care unit. Secondary objectives are the resolution of septic shock and the reduction of ICU LOS (length of stay).
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients admitted to the ICU in septic shock
- •All patients that develop septic shock while in the ICU
排除标准
- •Age less than 14 years
- •Pregnancy
- •Estimated life expectancy (due to comorbidities) less than 90 days
- •Presence of relative or absolute contraindications to CPFA
- •Admission from an other ICU where the patient remained for more than 24 hours
- •Absence of informed consent
结局指标
主要结局
Hospital Mortality
时间窗: At the discharge from the latest hospital (on average 30.3 days)
For patients discharged to other hospital, it will be intended as mortality at the discharge from the latest hospital in which the patients stayed.
次要结局
- Septic Shock Resolution Measured as Number of Days Free of Vasoactive Drugs From Randomization(15 days from randomization)
- Mortality Within 90 Days From Randomization(90 days from randomization)
- ICU LOS Reduction Measured as Days Not Spent in the ICU During the First 30 Days From Randomization(30 days from randomization)