Duration and Adverse Events of Non-cuffed Catheter in Patients With Hemodialysis : a Multicenter Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 1,400
- 主要终点
- Bloodstream infection due to central venous catheter
研究概览
简要总结
The duration and adverse events of non-cuffed catheter in patients with hemodialysis will be investigated by multicenter prospective cohort. Totally, 1,400 patients with chronic renal failure requiring hemodialysis will be enrolled. 900 patients will be given right internal jugular catheterization, and the other 500 patients unsuitable for right internal jugular catheterization will receive femoral catheterizations. Every patient will be followed-up for six months. During following-up period, the duration time and adverse events of non-cuffed catheter will be recorded in details, including inadequate hemodialysis blood flow, venous stenosis, venous thrombosis, infection, catheter thrombosis and so on. The central vein will be evaluated by CT Angiography to identify its stenosis at last visit after 6 months. This multicentre trial will provide evidence to develop guideline for duration time of using non-cuffed catheter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Chronic renal failure requiring hemodialysis.
- •No medical history of central vena catheterization.
- •Maintenance hemodialysis after central vena catheterization.
- •Signed informed consent.
排除标准
- •Had been performed central venous puncture or catheterization before.
- •Can not use heparin.
- •Refused to sign the informed consent.
- •Advanced cancer patients.
- •With or will take arteriovenous fistula surgery in right arm.
- •Other inappropriate situation
结局指标
主要结局
Bloodstream infection due to central venous catheter
时间窗: up to 3 months
Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
Central venous catheter exit site infection
时间窗: up to 3 months
Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
Inadequate hemodialysis blood flow
时间窗: up to 3 months
Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
Central venous catheter thrombosis
时间窗: up to 3 months
Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
venous thrombosis
时间窗: up to 3 months
Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
venous stenosis
时间窗: up to 3 months
Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
Duration time of non-cuff catheter
时间窗: up to 3 months
Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
次要结局
- Long term occurrence of venous stenosis(6 months)
- Effects on ECG(From baseline to 6months)
- Safety Evaluation(From baseline to 6months)
研究者
Changlin Mei
Professor, Director, Division of Nephrology
Shanghai Changzheng Hospital