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临床试验/NCT06236984
NCT06236984已完成不适用

Retrospective Data Analysis of CKRT Treatments in Adult Mode With multiFiltratePRO

Fresenius Medical Care Deutschland GmbH3 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
3
主要终点
Analysis of treatments with multiFiltratePRO

研究概览

简要总结

The multiFiltratePRO is a device for extracorporeal blood purification treatments.

In this retrospective analysis, the treatments of patients who received at least one treatment with the investigational device as mentioned between January 2015 and January 2024 will be documented in a chronological order. No further control treatments will be investigated in this one-arm design. The design is considered to be appropriate to reflect daily clinical practice and to contribute to empirical evidence of performance of the multiFiltratePRO system.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

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

  • All patients with an indication for the extracorporeal blood treatment suffering from AKI who received CKRT adult mode treatment for at least once with: Heparin-Continuous veno-venous hemofiltration Hep-CVVH (Pre CVVH, Post CVVH and Pre-Post CVVH), Heparin-Continuous veno-venous hemodialysis Hep-CVVHD, Heparin-Continuous veno-venous hemodiafiltration Hep-CVVHDF (Pre-CVVHDF and Post-CVVHDF), Citrate-Calcium(Ci-Ca)-CVVHD, Citrate-Calcium(Ci-Ca) CVVHDF, between January 2015 and January 2024, with the investigational device, have to be included in the study in chronological order.
  • No age restriction for heparin modes
  • Age ≥ 18 years for Ci-Ca modes at treatment start
  • Patient´s body weight ≥ 40kg irrespective of age
  • Acute Kidney Injury (AKI) OR chronic dialysis patients with clinical indication for CKRT

排除标准

  • Participation in an interventional clinical study during the retrospectively collected CKRT treatment data
  • Previous participation in the same study
  • No study-specific exclusion criteria based on contraindications due to the retrospective character of the study

结局指标

主要结局

Analysis of treatments with multiFiltratePRO

时间窗: documentation of max.7 treatment days

Performance data of defined multiFiltratePRO CKRT treatments in adult mode with regard to fluid balance (effluent dose) are analysed

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (3)

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