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临床试验/NCT03683563
NCT03683563Unknown不适用

A Prospective, Interventional Study to Investigate the Impact of Different Citrate Concentrations as Locking Solutions on Development of Biofilm and Function of Hemodialysis Catheters

University Medical Centre Ljubljana2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年4月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
catheter dysfunction

研究概览

简要总结

Evidence that supports using certain concentration of trisodium citrate as a locking solution for hemodialysis catheters has not yet been established. Higher concentrations of trisodium citrate are more effective in preventing thrombosis, formation of blood clots, preventing infections and biofilm formation, but due to potential side effects, their use is limited. The aim of the study is to compare the impact of two different concentrations of tri-sodium citrate solution (30% and 4%) on the formation of biofilms in hemodialysis single-volume jugular hemodialysis catheters and to determine the effectiveness of prevention of dysfunction of hemodialysis catheters.

详细描述

AIM OF THE STUDY:

The aim of the study is to compare the impact of two different concentrations of trisodium citrate solution (30% and 4%) on the formation of biofilms in hemodialysis single-volume jugular hemodialysis catheters and to determine the effectiveness of prevention of dysfunction of hemodialysis catheters.

Investigators will compare the influence of two different concentrations of trisodium citrate solutions as a locking solutions for hemodialysis catheters on the formation of intraluminal biofilm, the growth of microorganisms in the lumen of the hemodialysis catheter, and the occurrence of dysfunction of hemodialysis catheters in the same patient at the same time, under the same conditions as the same length and volume of hemodialysis catheters, catheter insertion time, duration of dialysis procedures, sex, age, co-morbidity, therapy and the presence of an infection.

BACKGROUND:

The population of patients this study will include are the ones who are being treated or are supposed to start the hemodialysis treatment at the Center for Acute and Complicated Dialysis, Department for Nephrology, UKC Ljubljana and for vascular approach have newly inserted or for any reason newly replaced two single-hemodialysis catheter to the left or right inner jugular vein.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • CKD on dialisys
  • AKI on dialisys

排除标准

  • systemic bacterial infection at the time of catheter insertion
  • local infection at the catheter insertion site
  • hypersensitivity to citrate
  • pregnancy

研究组 & 干预措施

4% citrate

Active Comparator

dialysis catheter locked with 4% sodium citrate

干预措施: 4% sodium citrate (Other)

30% citrate

Experimental

dialysis catheter locked with 30% sodium citrate

干预措施: 30% sodium citrate (Other)

结局指标

主要结局

catheter dysfunction

时间窗: within 6 months after catheter insertion

occurrence of dysfunction of dialysis catheter (expressed as catheter days)

次要结局

  • identification of microorganisms(an average of 1 year)
  • distribution of biofilm(an average of 1 year)

研究者

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

Bojan Medved

MD

University Medical Centre Ljubljana

研究点 (2)

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