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临床试验/NCT01597115
NCT01597115已完成不适用

ENhancing Maturation of Autogenous Arteriovenous Hemodialysis Access by Aggressive surveillaNCe With Duplex and Endovascular Treatment

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2012年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
2
主要终点
hemodialysis access maturation rate

研究概览

简要总结

The aim of this study is to evaluate whether Aggressive duplex surveillance after vascular access surgery with native vein for hemodialysis can increase the maturation rate of arteriovenous fistula. This study will be conducted as a single center, prospective, 1:1 randomized study. Enrolled patients will be randomized as a control group (Physical exam at 2 and 4 weeks after surgery) and duplex group (duplex study and physical exam at 2 and 4 weeks after surgery). Maturation of arteriovenous fistula will be evaluated at 8 weeks after surgery by duplex in all patients.

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
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • end stage renal disease
  • newly formed hemodialysis access with native vein
  • 20~70 years

排除标准

  • hemodialysis access surgery with ePTFE graft
  • hemodialysis access surgery with basilic vein transposition
  • hemodialysis access surgery with brachial vein transposition
  • cephalic vein < 2.5mm in diameter
  • radial artery diameter <2.0mm in radiocephalic arteriovenous fistula

结局指标

主要结局

hemodialysis access maturation rate

时间窗: 8 weeks after surgery

次要结局

  • factors predicting maturation failure(8 weeks after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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