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临床试验/NCT02312024
NCT02312024已完成不适用

International Registry on the Use of the CytoSorb®-Adsorber in ICU Patients

Jena University Hospital19 个研究点 分布在 3 个国家目标入组 1,434 人开始时间: 2015年1月最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (19)

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