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临床试验/NCT04388397
NCT04388397已完成不适用

Immediate-access Arteriovenous Versus Standard Arteriovenous Grafts in Hemodialysis Patients: A Randomized Clinical Study

Egyptian Biomedical Research Network2 个研究点 分布在 1 个国家目标入组 477 人开始时间: 2017年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
477
试验地点
2
主要终点
Success rate

研究概览

简要总结

Arteriovenous fistulae (AVF) are considered the main access for hemodialysis (HD). Arteriovenous grafts (AVGs) are an alternative access modality in patients with exhausted native venous access. Immediate-access arteriovenous grafts (IAAVGs) is a new modality in which dialysis can be started immediately to avoid complications of central venous catheters.

详细描述

The study aimed to evaluate and compare patency rate and complications of standard arteriovenous grafts (SAVGs) and immediate-access arteriovenous grafts (IAAVGs) in end stage renal disease (ESRD) patients for one year after the intervention. Patients were randomly divided into two groups: SAVGs group and IAAVGs group. Patients with ESRD with no chance for native AVF were examined clinically and by duplex ultrasonography preoperatively. Follow up was for one year. Primary end points were the success rate, complications rate (hematoma, pseudo-aneurysm, graft site infection, systemic bacteremia), time of first cannulation. Secondary end points were primary and secondary patency within one year.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult hemodialysis patients

排除标准

  • Significant cardiorespiratory comorbidities.
  • Peripheral vascular disease.
  • Pregnancy or lactation.
  • Severe bleeding disorders.

结局指标

主要结局

Success rate

时间窗: 24 hours

successful graft procedure

Primary Patency

时间窗: 1 year

Patency of hemodialysis access

次要结局

  • Complications rate(1 year)

研究者

发起方
Egyptian Biomedical Research Network
申办方类型
Network
责任方
Sponsor

研究点 (2)

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