A Randomised Controlled Trial of Taurolidine With Heparin for Prevention of Recurrence of Catheter Related Bacteraemia in Haemodialysis Patients.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Duration of bacteraemia-free catheter survival
研究概览
简要总结
The purpose of this study is to determine whether taurolidine with heparin locking solution prevents recurrence of central venous catheter related blood stream infections in haemodialysis patients.
详细描述
Infections related to long-term haemodialysis catheters are associated with significant morbidity. A high proportion of those people initially treated with antibiotics to clear a catheter infection develop a second infection within six months, necessitating the removal and replacement of the dialysis catheter.
This study will examine the efficacy of an antimicrobial catheter locking solution called taurolidine with heparin in preventing a second infection within six months of a significant infection. This solution will be compared with the solution used currently (heparin) which is left inside the catheter between dialysis sessions.
This is a clinical study given that antimicrobial catheter locks are thought to reduce the risk of blood stream infections and the ultimate need for catheter change. However, there is concern that the absence of an anticoagulant in the lock solution increases the risk of catheter thrombosis, again requiring a change of catheter but for a separate reason. It is unclear therefore whether a solution containing both taurolidine (an antimicrobial) and heparin (an anticoagulant) will increase catheter survival.
The results of this study will help guide the appropriate suse of locking solutions in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Haemodialysis patients established on dialysis for greater than 90 days who dialyse in-centre at any of the satellite dialysis units of Imperial College Healthcare NHS Trust
- •All patients with a recent catheter related bacteraemia with an identified organism grown on microbiological culture and treated without catheter removal will be eligible for inclusion.
排除标准
- •Those individuals in whom attempted catheter salvage is clinically not indicated.
- •Unable to provide informed consent
- •Known allergy to sodium citrate, heparin or taurolidine.
- •Bleeding diathesis or physical cause for active bleeding.
结局指标
主要结局
Duration of bacteraemia-free catheter survival
时间窗: Catheter survival measured up to six months from enrollment date.
次要结局
- Catheter related flow problems(Catheter survival measured up to six months from enrollment date.)
- Haemodialysis adequacy(Catheter survival measured up to six months from enrollment date.)
- Hospital admissions for catheter related problems including catheter removal(Catheter survival measured up to six months from enrollment date.)
- Erythropoietin resistance(Catheter survival measured up to six months from enrollment date.)