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临床试验/NCT07655544
NCT07655544尚未招募不适用

Impact of a Tunneled Hemodialysis Catheter With Endexo® Technology on Catheter Dysfunction Compared With Historical Catheter Dysfunction Data in Standard Catheters (Silicone or Polyurethane): A Pilot Study

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年8月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1

研究概览

简要总结

There is evidence that central venous catheters made of the permanent and non-eluting integral polymer Endexo® are more resistant to intraluminal thrombosis. This has a direct reducing effect on catheter malfunctions. Indirectly, due to reduced handling of the dysfunctional catheter, this may lead to a diminished rate of catheter related infections. Since catheter malfunctions and infections represent leading complications in a dialysis population, dialysis catheters produced with Endexo® technology have the potential to have beneficial clinical effects. In addition to improving patient outcomes, this could also reduce overall costs. In this pilot study the tunneled hemodialysis catheter BioFlo Duramax with Endexo® technology (Merit Medical, Utah, USA) will be compared with historical catheter dysfunction rates in standard tunneled dialysis catheters (silicone or polyurethane) in chronic dialysis population.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

入选标准

  • Adult patients aged greater than 18 years
  • Written informed consent
  • Requirement for hemodialysis using a tunneled dialysis catheter

排除标准

  • Children aged less than 18 years
  • Uncontrolled infection; defined as positive blood culture in the past seven days before catheter insertion and/ or elevated C-reactive protein [CRP >5 mg/dl (normal <0.5 mg/dl)] at screening

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Guerkan SENGOELGE

Assoc. Prof. Priv.-Doz. Dr. med.univ.

Medical University of Vienna

研究点 (1)

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