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Completed

NCT Number: NCT02705417

Maximizing Native Arteriovenous Fistulae Rates.

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.

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Key information

Conditions

Kidney Failure Arteriovenous Fistula Arteriovenous Malformations Arteriovenous Shunt Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fistula Hemodialysis Kidney Diseases Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases Vascular Diseases Vascular Fistula Vascular Malformations

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

preoperative color Doppler ultrasonographic vascular mapping

Procedure

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.

Other names: vascular mapping, pre-operative mapping

Physical Examination

Procedure

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.

Other names: clinical examination

Medical history

Procedure

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

native arteriovenous fistula construction

Procedure

surgigal creation of native arterial and venous anastomoses

Arteriovenous graft placement

Procedure

surgical placement of arteriovenous graft

Other names: Polytetrafluoroethylene (PTFE) synthetic graft

Primary outcomes

  1. number of native AVF constructed

    Time frame: in 1 month

Secondary outcomes

  1. primary patency rates

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Medifil AE

Other

Collaborators

  • International Renal Research Institute Vicenza

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Mar 10, 2016
Registry last updated
Mar 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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