COMPACT (COMbining Plasma-filtration and Adsorption Clinical Trial): Efficacy and Safety of 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
- 184
- 试验地点
- 38
- 主要终点
- Hospital mortality (for patients discharged to other hospital, it will be intended as mortality at the discharge from the latest hospital in which the patients stayed)
研究概览
简要总结
The study objective is to clarify whether the application of CPFA (coupled plasma-filtration adsorption) in addition to the current clinical practice is able to reduce mortality and prevent organ failures 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 CPFA in addition to the current clinical practice is able to reduce mortality and prevent organ failures in septic shock patients in intensive care unit.
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
- •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 18 years
- •Pregnancy
- •Cardiopulmonary resuscitation
- •Cerebral coma
- •Metastatic cancer
- •Presence of relative or absolute contraindications to CPFA
- •Estimated life expectancy less than 2 weeks
- •Already included in the study
- •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 (for patients discharged to other hospital, it will be intended as mortality at the discharge from the latest hospital in which the patients stayed)
时间窗: At the discharge from the latest hospital
次要结局
- Mortality within 90 days from randomization(90 days from randomization)
- New organ failures (assessed through SOFA score)(Within ICU stay)
- Days not spent in the ICU during the first 30 days from randomization(30 days from randomization)