Clinical trial NCT02705417: Maximizing Native Arteriovenous Fistulae Rates.
Official title: Maximizing Native Arteriovenous Fistulae Rates. Is Routine Colour Doppler Vascular Mapping in Pre-operative Planning of Value? A Retrospective Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Failure
Arteriovenous Shunt
Hemodialysis
Keywords: arteriovenous fistula
colour Doppler
physical examination
renal dialysis
retrospective studies
Lead sponsor: Medifil AE
Sponsor class: OTHER
Collaborators: name: International Renal Research Institute Vicenza
First posted: 2016-03-10
Enrollment: 136
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with dialysis dependent end stage renal disease with first time permanent vascular access, more specifically native arteriovenous fistula or arteriovenous grafts.

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.

Eligibility criteria: 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

Primary outcomes:
measure: number of native AVF constructed
timeFrame: in 1 month
Secondary outcomes:
measure: primary patency rates
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Medifil AE Private Hemodialysis Centre
name: Ioannis E. Giannikouris, PhD
role: PRINCIPAL_INVESTIGATOR
References: