Improving Arteriovenous Fistula Patency

Summary

All vascular access guidelines recommend monitoring and surveillance protocols to prevent vascular access complications in hemodialysis units.

However, in the case of second generation screening techniques which determine access blood flow measurement (QA), there is a huge controversy about it´s efficiency.

Although multiple observational studies find a decrease in the thrombosis rate and an increased primary assisted patency survival related to the use of these techniques, a recently published meta-analysis find contradictory results in the randomized controlled trials, affirming that the measurement of QA is useless in grafts and questionable in native arteriovenous fistulae (AVF).

We have designed a multicenter, prospective, open label, controlled, randomized trial, to prove the usefulness of the QA measurement using two complementary second generation techniques, Doppler ultrasound and Transonic dilution method, compared to the classical monitoring and surveillance methods.

The primary endpoint will be a reduction in the thrombosis rate with an increased assisted primary patency survival, and a cost effectiveness economic analysis.

As secondary endpoints we will analyze the impact over non-assisted primary patency survival and secondary patency survival.

Conditions

• Thrombosis

Interventions

DEVICE

Second generation surveillance of AVF

Doppler ultrasound and transonic dilution method technique will be performed in the experimental group quarterly. QA will be measured by both techniques and haemodynamic repercussion stenosis will be evaluated by doppler ultrasound.

PROCEDURE

vital signs

Effective blood flow, venous pressure, arterial pressure, at the beginning and at the end of the dialysis session

PROCEDURE

physical examination of AVF

Predialysis physical examination of AVF every dialysis session.

PROCEDURE

ktv test

Weekly ktv measurement using biosensors. In patients who have been dialyzed in monitors with no biosensors, ktv will be measured monthly using monocompartimental Daugirdas equation

PROCEDURE

urea method

Quarterly recirculation with urea method.

Sponsors & Collaborators

• Hospital Infanta Sofia

  lead OTHER

Principal Investigators

• ANTONIO CIRUGEDA, MD · HOSPITAL UNIVERSITARIO INFANTA SOFIA

• SILVIA CALDES, MD · HOSPITAL UNIVERSITARIO INFANTA SOFIA

• YESIKA AMEZQUITA, MD · CLINICA FUENSANTA

• JUAN MANUEL LOPEZ, PhD · HOSPITAL UNIVERSITARIO GREGORIO MARAÑON

• SORAYA ABAD, MD · HOSPITAL UNIVERSITARIO GREGORIO MARAÑON

• INES ARAGONCILLO, MD · Hospital Infanta Sofia

• BORJA QUIROGA, MD · HOSPITAL GREGORIO MARAÑON

• FERNANDO DE ALVARO, PhD · Hospital Infanta Sofia

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

95 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-09-01

Primary Completion

2015-09-29

Completion

2015-09-29

Countries

• Spain

Study Locations