NCT02111655

Improving Arteriovenous Fistula Patency

Second Generation Surveillance Techniques to Prevent Thrombosis and Increase Assisted Primary Patency in Native Arteriovenous Fistula. A Prospective Controlled Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 212 (actual)
• Sponsor: Hospital Infanta Sofia · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Definition: 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. For Patient Registries: Clinical data repository (CDR) paper notebook will contain all baseline patient characteristics and the information related to vascular access. These data will be collected by the different investigators and reviewed and included in data base by the study´s monitor. This information will be included in a centralized computer database (SPSS 15.0 computer system) and encoded in order to preserve patients´ confidentiality.

Conditions

• Thrombosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-09-01
• Primary completion: 2015-09-29
• Completion: 2015-09-29
• First posted: 2014-04-11
• Last updated: 2017-06-20

Locations

5 sites across 1 country: Spain