A Prospective, Interventional Study to Investigate the Impact of Different Citrate Concentrations as Locking Solutions on Development of Biofilm and Function of Hemodialysis Catheters
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
- 否
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
dialysis catheter locked with 4% sodium citrate
干预措施: 4% sodium citrate (Other)
30% citrate
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
Bojan Medved
MD
University Medical Centre Ljubljana