跳至主要内容
临床试验/NCT02705417
NCT02705417已完成不适用

Maximizing Native Arteriovenous Fistulae Rates. Is Routine Colour Doppler Vascular Mapping in Pre-operative Planning of Value? A Retrospective Study.

Medifil AE0 个研究点目标入组 136 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
136
主要终点
number of native AVF constructed

研究概览

简要总结

The purpose of our study is to compare physical examination alone to color Doppler ultrasonography (CDUS) vascular mapping and physical examination in terms of outcomes of vascular access and long-term patency.

详细描述

Fistula maturation is a complex vascular remodelling process that requires vessel dilation, increases in volume flow rates in the feeding artery and afferent vein and structural alterations of the vascular wall. The understanding of these procedures and the factors involved in promoting maturation is limited. In this context, one of the major areas requiring investigation is the identification of clinically useful pre-operative predictors of access outcome.

Traditionally, the selection of vascular access and the eligibility for native arteriovenous fistula construction was mainly determined by findings of clinical examination. However, in addition to a complete history and physical examination, National Kidney Foundation/Dialysis Outcome Quality Initiative (NFK/DOQI) recommended that routine pre-operative color Doppler ultrasonographic vascular mapping should be performed in all hemodialysis patients who are candidates for access formation. This concerns the routine implementation of a non-invasive, safe and cost-effective method that permits the identification of vessels that are suitable for arteriovenous fistula (AVF) construction, acknowledging that supporting Level I evidence is still lacking. Indeed, available data supporting the significance of mapping on access maturation and patency rates are limited and conflicting.

The aim of the present study is to compare the type of preoperative assessment, physical examination alone to combined CDUS vascular mapping and physical examination, to outcomes of performed vascular access procedures with respect to type selection and long-term patency at 12 months in hemodialysis patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • end stage renal disease

排除标准

  • poor life expectancy
  • congestive heart failure New York Heart Association stage 3 and over
  • candidates for tunneled catheters

结局指标

主要结局

number of native AVF constructed

时间窗: in 1 month

次要结局

  • primary patency rates(12 months)

研究者

发起方
Medifil AE
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ioannis Emmanouel Giannikouris

Assistant for the Medical Director

Medifil AE

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