Maximizing Native Arteriovenous Fistulae Rates.

Completed

• Conditions: Arteriovenous Shunt; Kidney Failure; Hemodialysis
• Interventions: Procedure: preoperative color Doppler ultrasonographic vascular mapping; Procedure: physical examination; Procedure: native arteriovenous fistula construction; Procedure: medical history; Procedure: arteriovenous graft placement

• Registration Number: NCT02705417
• Lead Sponsor: Medifil AE

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 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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2014-01
• Study Completion: 2015-01
• Status Verified: 2016-03
• Study First Submitted: 2016-03-02
• Study First Submitted QC: 2016-03-04
• Last Update Submitted: 2016-03-04
• Study First Posted: 2016-03-10
• Last Update Posted: 2016-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	native arteriovenous fistula construction	Patients in whom selection of vascular access relied upon physical examination and medical history, during pre-operative surgical assessment
Group B	physical examination	Patients who underwent vascular mapping using color Doppler Ultrasonography in addition to physical examination and history during pre-operative evaluation.
Group B	native arteriovenous fistula construction	Patients who underwent vascular mapping using color Doppler Ultrasonography in addition to physical examination and history during pre-operative evaluation.
Group B	arteriovenous graft placement	Patients who underwent vascular mapping using color Doppler Ultrasonography in addition to physical examination and history during pre-operative evaluation.
Group A	arteriovenous graft placement	Patients in whom selection of vascular access relied upon physical examination and medical history, during pre-operative surgical assessment
Group B	preoperative color Doppler ultrasonographic vascular mapping	Patients who underwent vascular mapping using color Doppler Ultrasonography in addition to physical examination and history during pre-operative evaluation.
Group A	physical examination	Patients in whom selection of vascular access relied upon physical examination and medical history, during pre-operative surgical assessment
Group B	medical history	Patients who underwent vascular mapping using color Doppler Ultrasonography in addition to physical examination and history during pre-operative evaluation.
Group A	medical history	Patients in whom selection of vascular access relied upon physical examination and medical history, during pre-operative surgical assessment

Primary Outcome Measures

Name	Time	Method
number of native AVF constructed	in 1 month

Secondary Outcome Measures

Name	Time	Method
primary patency rates	12 months