Comparison of Tesio and LifeCath Twin Permanent Dialysis Catheters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Blood Flow Rate at First Use After Insertion
研究概览
简要总结
This study aims to compare two available types of central venous haemodialysis catheters (lines) - CVCs, and will examine how easy they are to insert, complications, blood flow on dialysis over time, line loss, line clotting and infective events. It will examine whether the LifeCath type of CVC can deliver high blood flow rates from first use after insertion and equivalent function and complication rate to the Tesio type of CVC that is in use in our centre already. Complications relating to dialysis access make up 30% of admissions for haemodialysis patients and so this is a study that could benefit patients and their care providers.
详细描述
Complications relating to dialysis access make up to 30% of admissions in haemodialysis patients. Comparative studies of complications between dialysis lines can help physicians and patients choose the best CVC type. In addition determining a type of dialysis line that can deliver good blood flows from the outset can minimise length of hospital stay for access creation. This study aims to perform a head-to-head comparison of two very similar (twin catheter) dialysis lines and examine short and long-term function as well as complication rates at our centre.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >=18 years old
- •No history of prior central venous catheter insertion
- •Medically fit for procedure (able to lie flat, no haemodynamic instability)
- •No active infection (recent positive blood cultures, clinical signs of infection, CRP>100)
- •Able to give informed consent
- •Expected to survive more than 12 months after catheter insertion
排除标准
- 未提供
结局指标
主要结局
Blood Flow Rate at First Use After Insertion
时间窗: First haemodialysis session after insertion
次要结局
- Infective Episodes (Catheter & Non-catheter Related)(12 months)
- Achievement of Flow Rates>=450ml/Min at Dialysis Session(flow rate measured at each session; session at 12 months reported)
- Line Retention (Either/Both Lumens)(12 months)
- Catheter Dysfunction Requiring Use of Thrombolytic Agents(12 months)
- Complications at Catheter Insertion(Day 1)
- Recirculation Rates(12 months)