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临床试验/NCT01053117
NCT01053117终止2 期

Reducing Hemodialysis Catheter Use in in a Prevalent Hemodialysis Population; A Pilot Randomized Control Trial

Dr. Lisa Miller2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2009年2月最近更新:
适应症

试验速览

阶段
2 期
状态
终止
发起方
入组人数
3
试验地点
2
主要终点
The proportion of patients using a CVC in a prevalent hemodialysis population after the implementation of an algorithm protocol to convert the CVC to an AVF compared with patients who received current standard care.

研究概览

简要总结

To determine if a protocolized approach to converting hemodialysis central venous catheters (CVC) to arteriovenous fistulae will improve rates of functioning AVF and decrease CVC use.

详细描述

In order to receive dialysis, patients require repeated access to their bloodstream. This access can be either via a central venous catheter (CVC) or a surgically created arteriovenous fistula (AVF) or graft (AVG). This is a pilot randomized control trial of prevalent hemodialysis patients with a central venous catheter (CVC), to determine if a systematic approach using an algorithm protocol to convert the CVC to an AVF (arteriovenous fistula) will improve rates of functioning AVF and decrease CVC use. The algorithm (intervention group) will be compared to current practice (control group), a non-standardized approach at the discretion of the caring nephrologist and/or surgeon.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • > 18 years of age
  • Dialyzing with a CVC
  • Receiving hemodialysis three times weekly for > 3 months

排除标准

  • Awaiting peritoneal dialysis catheter insertion
  • Scheduled living donor transplant
  • Transient patients from out of province
  • Expected transfer to satellite dialysis unit within 6 months
  • Surgical plan for AVF (i.e. scheduled date)
  • Documented lack of suitable vasculature for AVF
  • Refusing AVF

结局指标

主要结局

The proportion of patients using a CVC in a prevalent hemodialysis population after the implementation of an algorithm protocol to convert the CVC to an AVF compared with patients who received current standard care.

时间窗: 9 months

次要结局

  • Proportion of patients with a maturing AVF(9 months)
  • The proportion of patients with a functioning AVF after the implementation of an algorithm protocol to convert the CVC to an AVF compared with patients who received current standard care.(9 months)
  • Primary fistula failure rate(9 months)
  • Incidence of AVF salvage procedures, including balloon angioplasty and accessory vein ligation, within 9 months of AVF creation(9 months)

研究者

发起方
Dr. Lisa Miller
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Lisa Miller

Dr. Lisa Miller

University of Manitoba

研究点 (2)

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