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临床试验/NCT02645682
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

West China Hospital2 个研究点 分布在 1 个国家目标入组 1,818 人开始时间: 2016年3月最近更新:
适应症

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

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kang Yan

professor; chief physician

West China Hospital

研究点 (2)

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