Clinical Trial: Maximizing Native Arteriovenous Fistulae Rates.

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief Summary: 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.

Detailed Summary:

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.

Sponsor: Medifil AE

Current Primary Outcome: number of native AVF constructed [ Time Frame: in 1 month ]

Original Primary Outcome: Same as current

Current Secondary Outcome: primary patency rates [ Time Frame: 12 months ]

Original Secondary Outcome: Same as current

Information By: Medifil AE

Dates:
Date Received: March 2, 2016
Date Started: January 2012
Date Completion:
Last Updated: March 4, 2016
Last Verified: March 2016