Maximizing Native Arteriovenous Fistulae Rates.

Medifil AE

Status: Completed

Conditions: Kidney Failure; Hemodialysis; Arteriovenous Shunt

Treatments: Procedure: native arteriovenous fistula construction; Procedure: medical history; Procedure: arteriovenous graft placement; Procedure: preoperative color Doppler ultrasonographic vascular mapping; Procedure: physical examination

Study type: Observational

Funder types: Other

Identifiers

NCT02705417

1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 136 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• end stage renal disease

Exclusion criteria

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

Trial design

136 participants in 2 patient groups

Group A

Description:

Patients in whom selection of vascular access relied upon physical examination and medical history, during pre-operative surgical assessment

Treatment:

Procedure: physical examination

Procedure: arteriovenous graft placement

Procedure: native arteriovenous fistula construction

Procedure: medical history

Group B

Description:

Patients who underwent vascular mapping using color Doppler Ultrasonography in addition to physical examination and history during pre-operative evaluation.

Treatment:

Procedure: physical examination

Procedure: preoperative color Doppler ultrasonographic vascular mapping

Procedure: arteriovenous graft placement

Procedure: native arteriovenous fistula construction

Procedure: medical history