A Randomised Controlled Trial Comparing Bacteraemia Rates in Closed Luer Lock Access Devices(TEGO) With Standard Devices in the Outpatient Haemodialysis Population
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Bacteraemia rates in the needle free access devices(TEGO) when compared to current practice
研究概览
简要总结
This study will be a randomised controlled trial examining whether a new type of needle free access device(TEGO) is associated with less episodes of infection of dialysis lines, when compared to the current gold standard.
The investigators hypothesise that there will be less handling of the dialysis line by nursing staff and thus this will lead to lower rates of infection. The investigators will also assess whether these access devices lead to alterations in catheter blood flow rates when compared to the current gold standard.
详细描述
Introduction
Infection is an important cause of morbidity and mortality in patients with ESKD. Examining the USRDS database, it is the second leading cause of death in these patients . Several studies in the past number of years have highlighted permanent vascular access devices as independent risk factors for the development of sepsis .
Approximately 50% of haemodialysis patients in Beaumont Hospital use permanent central catheters, often while awaiting alternative vascular access, such as arterio-venous fistulae or when other avenues of vascular access have been exhausted. International data has shown that patients with permanent vascular access devices have 50% higher infection rates compared to those with a native fistula .
Permanent central venous catheters used in haemodialysis are tunnelled cuffed dual lumen catheters usually composed of silicone or polyurethane materials. These are usually placed in the right internal jugular vein. Tunnelled haemodialysis catheters are placed in the radiology department under fluoroscopic guidance.
The presence of catheter related bacteraemia is often treated with intravenous antibiotics such as vancomycin or gentamycin, however a study of 100 haemodialysis patients in Ann Int Med in 1997 has shown that attempts to treat bacteraemia without removal of the catheter usually fail . In such cases, removal of the catheter and insertion of another at either the same or another site is necessary.
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
- •Patients recruited will be over 18 and have been on haemodialysis for greater than one month, have permanent cuffed vascular access lines in place and will be receiving haemodialysis through these lines three times per week.
- •Patients will not have had a documented episode of bacteraemia or sepsis for greater than 4 weeks, and will not be using antibiotic coated dialysis lines.
排除标准
- •Patients with immunosuppressive illnesses such as HIV, cancer or patients who regularly use glucocorticoids.
结局指标
主要结局
Bacteraemia rates in the needle free access devices(TEGO) when compared to current practice
时间窗: 1 year
New needle free access devices will be compared to current 'bung' devices. Patients will be randomly assigned to both groups, and rates of bacteraemia will be compared between both groups
次要结局
- Catheter blood flow rates in study device compared to control(1 year)
- Rates of line thrombosis in study group compared to control group(1 year)