Maximizing Native Arteriovenous Fistulae Rates.

Hemodialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02705417
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• First received: March 2, 2016
• Last updated: March 4, 2016
• Start date: January 2012
• Est. completion date: January 2015

Study information

• Verified date: March 2016
• Source: Medifil AE
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ministry of Health and Welfare
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: January 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Arteriovenous Shunt
• Hemodialysis
• Kidney Failure
• Renal Insufficiency

Intervention

Procedure:
• preoperative 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.
• physical 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
medical history with respects to diabetes mellitus, coronary heart disease, peripheral vascular disease
• native arteriovenous fistula construction
surgigal creation of native arterial and venous anastomoses
• arteriovenous graft placement
surgical placement of arteriovenous graft

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medifil AE	International Renal Research Institute Vicenza

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of native AVF constructed		in 1 month	No
Secondary	primary patency rates		12 months	No