NCT Number: NCT02111655
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.
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Notify Me18 year–95 year
All sexes
Interventional
Not applicable
Hospital Universitario Infanta Sofia, San Sebastián de los Reyes, Madrid, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Doppler ultrasound: M-Turbo. Sonosite., Transonic dilution method: Transonic System Inc HD-03
Effective blood flow, venous pressure, arterial pressure, at the beginning and at the end of the dialysis session
Predialysis physical examination of AVF every dialysis session.
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
Quarterly recirculation with urea method.
Time frame: Up to 3 years follow up
Differences in assisted primary patency rates (thrombosis free access survival) in AVF between the two groups: control group in which classical monitoring and surveillance techniques are applied and experimental group in which Doppler ultrasound and transonic were performed every three months in addition to classical methods.
Cost efficacy analysis in both groups will be done, measuring all vascular access (VA) related health care spending (VA hospitalization costs, central venous catheter (CVC) placements, surgeries and endovascular procedures will be recorded).
Time frame: Up to 1 year follow up
Time frame: Up to 2 years follow up
It will be evaluated the positive and negative predictive value of each second generation technique, doppler ultrasound and Transonic dilution method. The accuracy of these techniques will be compared to determine which one show more benefits detecting pathology of AVF.
Time frame: Up to 3 years follow up.
There will be always two observers for each doppler ultrasound (same observers for same AVF). Differences among different quarterly measures in stable AVF will be evaluated, as well as the differences between the two observers in QA measurement.
Time frame: Up to 3 years follow up
It will be evaluated if there is any influence of age, body mass index, use of antiplatelet therapy, anticoagulant therapy or the use of pentoxifylline in the risk of thrombosis of AVF
Time frame: Up to 2 years follow up
Time frame: Up to 3 years follow up
It will be evaluated the positive and negative predictive value of each second generation technique, doppler ultrasound and Transonic dilution method. The accuracy of these techniques will be compared to determine which one show more benefits detecting pathology of AVF.
Time frame: Up to 3 years follow up
Hospital Infanta Sofia
Other
Second Generation Surveillance Techniques to Prevent Thrombosis and Increase Assisted Primary Patency in Native Arteriovenous Fistula. A Prospective Controlled Trial.
Acronym: METTRO
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