International Registry on the Use of the CytoSorb®-Adsorber in ICU Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,434
- 试验地点
- 19
- 主要终点
- Difference between mortality predicted by scoring systems (APACHE II/SAPS II, EuroSCORE II) and actual mortality within 30 days after intervention
研究概览
简要总结
Registry on the use of the CytoSorb® adsorber in ICU patients.
详细描述
The aim of this registry is to record the use of CytoSorb® under real life conditions in as many cases as possible (preferably all or, at least, in a representative sample). All CytoSorb® applications in different clinical settings and in all patients who are treated with this technology in Germany, Austria and Switzerland (target population) are planned to be included.
The objectives of the registry are collection of real-life data on a broad scale, their centralized, structured and comprehensive documentation, and a controlled data exchange. The gathered information will be used to augment the knowledge on the clinical efficacy of the technology, to optimize the quality of its therapeutic application, and to identify and promptly handle possible complications related to the use of CytoSorb®. The registry will record all relevant information in the course of product use, e.g. diagnosis, comorbidities, course of the condition, treatment, concomitant medication and clinical laboratory parameters.
The registry will inform physicians of different medical specialties about the range of possible applications of CytoSorb® and invite them to contribute their own experiences to the registry. This is done by giving them access to their own data and to the results of periodic analyses (for contributing participants), and via publications of the results (for participants and external interested parties)
The CytoSorb® registry will provide the data base for justified and optimized decisions. An active form of data collection where data is prospectively collected by qualified staff is particularly suited for this purpose.
Registry data might help closing knowledge gaps and open practical issues. Due to the patient group's heterogeneity, the registry can identify sub-groups, assess their risk-benefit-profile and examine their safety profile. Registry data are absolutely essential for assessing a therapy's significance within the healthcare landscape.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Use of the CytoSorb® adsorber
- •Age ≥ 18 years
- •Signed informed consent
排除标准
- 未提供
结局指标
主要结局
Difference between mortality predicted by scoring systems (APACHE II/SAPS II, EuroSCORE II) and actual mortality within 30 days after intervention
时间窗: days
次要结局
- - Duration of renal replacement therapy (days)(days)
- - Concentration of biomarkers IL-6, CRP, PCT, myoglobin, free hemoglobin(days)
- - Duration of vasopressor therapy (days)(days)
- - Organ function (SOFA - score-difference)(days)
- - Length of hospital and ICU stay (days)(days)
- - Duration of mechanical ventilation (days)(days)
