NCT05953675进行中（未招募）不适用
Ethanol Lock and Risk of Catheter Related Blood Stream Infection in Patients With Haemodialysis Catheter
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Time to hemodialysis catheter-related bacteremia
研究概览
简要总结
The aim of this study is to examine the effect of ethanol (70%) as lock-solution after hemodialysis on:
- The frequency of dialysis catheter-related bacteremia among patients under observation of potential complications
- Other complications of the use of hemodialysis-catheters eg. dysfunction of the catheter due to thrombosis.
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
- •Age at or above 18 years.
- •Currently recieving hemodialysis treatment with tunneled intravenous hemodialysis-catheter
- •Written informed consent after verbal and written information is given.
排除标准
- •Pregnancy or breastfeeding
- •Intolerance to ethanol or contraindications for the use of ethanol. Eg. possible interactions, former alcohol dependency.
- •Earlier infections to current catheter (exit-site, tunnel-infection and catheter-related bloodstream infection
研究组 & 干预措施
Control arm
Active Comparator
Standard procedure of isotonic saline with heparin as lock-solution
干预措施: Isotonic saline with heparin (Drug)
Intervention arm
Experimental
3 mL of 70% ethanol as lock-solution
干预措施: Ethanol 70% (Drug)
结局指标
主要结局
Time to hemodialysis catheter-related bacteremia
时间窗: 2 years
次要结局
- Time to removal of catheter due to infection(2 years)
- Life quality(2 years)
- Time to exit-site infection(2 years)
- Complications eg. catheter-thrombosis and pulmonary embolus(2 years)
- Economical costs(2 years)
- Incidence of hemodialysis catheter-related bacteremia(2 years)
研究者
研究点 (1)
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