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Maximizing Native Arteriovenous Fistulae Rates.

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02705417
Enrollment
136
Registered
2016-03-10
Start date
2012-01-31
Completion date
2015-01-31
Last updated
2016-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure, Arteriovenous Shunt, Hemodialysis

Keywords

arteriovenous fistula, colour Doppler, physical examination, renal dialysis, retrospective studies

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.

Interventions

PROCEDUREpreoperative color Doppler ultrasonographic vascular mapping

Preoperative color Doppler ultrasonographic vascular mapping was performed with linear probe. The patient extremity under scrutiny was placed under support, with tourniquet augmentation. Vessels were examined in both short (transverse) and long (longitudinal) axis. Anatomical variations, wall morphology and internal diameters at the antecubital fossa, the proximal (cranial), mid and distal (caudal) third of the arm and forearm were assessed in both extremities. Veins were evaluated for compressibility and adequate drainage to deep venous system. The presence of sclerotic, thrombosed and fibrosed segments were noted. Doppler waveforms were obtained in the long axis and volume flow (VF) calculated for arteries selected for potential access construction.

PROCEDUREphysical examination

Arterial pulse examination, differential blood pressure measurements and the Allen test in both extremities. Inspection of the superficial venous system with tourniquet enhancement in the arm was performed during venous assessment.

medical history with respects to diabetes mellitus, coronary heart disease, peripheral vascular disease

PROCEDUREnative arteriovenous fistula construction

surgigal creation of native arterial and venous anastomoses

surgical placement of arteriovenous graft

Sponsors

International Renal Research Institute Vicenza
CollaboratorOTHER
Medifil AE
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
number of native AVF constructedin 1 month

Secondary

MeasureTime frame
primary patency rates12 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026