NCT02645682Unknown不适用
The Effects of Anti-infective Central Venous Catheter(CVC) on Catheter-related Bloodstream Infection(CRBSI) in Critical Care Patients: a Multiple-center, Randomized, Control Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 1,818
- 试验地点
- 2
- 主要终点
- catheter-related bloodstream infection
研究概览
简要总结
The purpose of this study is to investigate the effect of anti-infective central venous catheter(Certofix®Protect) on reducing catheter-related bloodstream infection in critically ill patients in China, and the relationship between catheter-related bloodstream infection and catheter-related 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
- •adult patients in intensive care unit (ICU)（age ≥ 18 years）
- •needs double lumen CVC more than 5 days
- •Signed informed consent
排除标准
- •thrombosis in target and/or contralateral vein
- •pregnancy or lactating women
- •unlikely to survive for more than 1 month
- •bad prognosis
- •suspected catheter-related infection
- •replacement CVC in original site through guide wire
- •severe burn
- •situation that is not suitable for CVC, including allergic to CVC material, thrombosis in target vein, infection of puncture site, coagulation disorder, abnormal anatomy
- •already in this study
- •participated in other studies within 3 months
研究组 & 干预措施
anti-infection CVC (Certofix®protect)
Experimental
intervention group
干预措施: anti-infection CVC (Device)
normal CVC (Certofix®)
Active Comparator
control group
干预措施: normal CVC (Device)
结局指标
主要结局
catheter-related bloodstream infection
时间窗: through study completion, an average of 2 years
number of participants with catheter-related bloodstream infection
次要结局
- catheter-related thrombosis(through study completion, an average of 2 years)
- all cause mortality(through study completion, an average of 2 years)
研究者
Kang Yan
professor; chief physician
West China Hospital
研究点 (2)
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