Study Results
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Basic Information
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COMPLETED
NA
212 participants
INTERVENTIONAL
2012-09-01
2015-09-29
Brief Summary
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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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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Clasical Surveillance of AVF
Classical evaluation of AVF includes:
1. Vital sings and predialysis physical examination of AVF every dialysis session.
2. Effective blood flow, venous pressure, arterial pressure, at the beginning and at the end of the dialysis session.
3. Weekly ktv test using biosensors or monthly if using monocompartimental Daugirdas equation.
4. Quarterly recirculation with urea method.
Following Spanish Nephrology VA guidelines will be consider as alarm criteria:
1.25% Increased venous pressure. 2.25% Decreased pump blood flow. 3.0,2 ktv decreased compared with previous measurement. 4.\> 10% recirculation using urea method. 5.Prolonged coagulation time or cannulation difficulties in 3 consecutive dialysis sessions.
6.Pathologic physical examination with any other criteria.
vital signs
Effective blood flow, venous pressure, arterial pressure, at the beginning and at the end of the dialysis session
physical examination of AVF
Predialysis physical examination of AVF every dialysis session.
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
urea method
Quarterly recirculation with urea method.
Second generation surveillance of AVF
In addition to the classical surveillance and monitoring methods, in the experimental group Doppler ultrasound and transonic dilution method will be performed on a quarterly basis.
In addition to the classical alarm criteria and derived from the results in Doppler ultrasound an transonic dilution method the following alarm criteria would also be considered in the experimental group:
1. 25% or higher decreased in QA compared with previous measurement.
2. QA lower than 500 ml/min.
3. Stenotic area with a higher than 50% reduction of blood vessel lumen would be considered as alarm criteria only if it comes with a haemodynamic repercussion criteria defined as Peak systolic velocity (PSV) higher than 400 cm/sc, aliasing, or PSV ratio stenosis/pre-stenosis higher than 3.
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.
vital signs
Effective blood flow, venous pressure, arterial pressure, at the beginning and at the end of the dialysis session
physical examination of AVF
Predialysis physical examination of AVF every dialysis session.
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
urea method
Quarterly recirculation with urea method.
Interventions
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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.
vital signs
Effective blood flow, venous pressure, arterial pressure, at the beginning and at the end of the dialysis session
physical examination of AVF
Predialysis physical examination of AVF every dialysis session.
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
urea method
Quarterly recirculation with urea method.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age between 18 and 95 years old.
* Functioning native AVF.
* Patients with end stage renal disease (ESRD) undergoing hemodialysis program for at least three months.
Exclusion Criteria
* Hospitalization of any cause in the previous month.
* VA related complications or dysfunction in the previous three months.
18 Years
95 Years
ALL
No
Sponsors
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Hospital Infanta Sofia
OTHER
Responsible Party
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Antonio Cirugeda
Principal Investigator
Principal Investigators
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ANTONIO CIRUGEDA, MD
Role: PRINCIPAL_INVESTIGATOR
HOSPITAL UNIVERSITARIO INFANTA SOFIA
SILVIA CALDES, MD
Role: STUDY_CHAIR
HOSPITAL UNIVERSITARIO INFANTA SOFIA
YESIKA AMEZQUITA, MD
Role: STUDY_CHAIR
CLINICA FUENSANTA
JUAN MANUEL LOPEZ, PhD
Role: STUDY_CHAIR
HOSPITAL UNIVERSITARIO GREGORIO MARAÑON
SORAYA ABAD, MD
Role: STUDY_CHAIR
HOSPITAL UNIVERSITARIO GREGORIO MARAÑON
INES ARAGONCILLO, MD
Role: STUDY_CHAIR
Hospital Infanta Sofia
BORJA QUIROGA, MD
Role: STUDY_CHAIR
HOSPITAL GREGORIO MARAÑON
FERNANDO DE ALVARO, PhD
Role: STUDY_CHAIR
Hospital Infanta Sofia
Locations
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Hospital Universitario Infanta Sofia
San Sebastián de los Reyes, Madrid, Spain
Centro de Diálisis Los Enebros
Madrid, , Spain
Hospital Universitario Gregorio Marañon
Madrid, , Spain
Dialcentro
Madrid, , Spain
Clinica Fuensanta
Madrid, , Spain
Countries
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References
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Aragoncillo I, Abad S, Caldes S, Amezquita Y, Vega A, Cirugeda A, Moratilla C, Ibeas J, Roca-Tey R, Fernandez C, Macias N, Quiroga B, Blanco A, Villaverde M, Ruiz C, Martin B, Ruiz AM, Ampuero J, de Alvaro F, Lopez-Gomez JM. Adding access blood flow surveillance reduces thrombosis and improves arteriovenous fistula patency: a randomized controlled trial. J Vasc Access. 2017 Jul 14;18(4):352-358. doi: 10.5301/jva.5000700. Epub 2017 Apr 20.
Aragoncillo I, Amezquita Y, Caldes S, Abad S, Vega A, Cirugeda A, Moratilla C, Ibeas J, Roca-Tey R, Fernandez C, Quiroga B, Blanco A, Villaverde M, Ruiz C, Martin B, Ruiz AM, Ampuero J, Lopez-Gomez JM, de Alvaro F. The impact of access blood flow surveillance on reduction of thrombosis in native arteriovenous fistula: a randomized clinical trial. J Vasc Access. 2016 Jan-Feb;17(1):13-9. doi: 10.5301/jva.5000461. Epub 2015 Sep 18.
Other Identifiers
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3598
Identifier Type: OTHER
Identifier Source: secondary_id
210443-031132-261233
Identifier Type: -
Identifier Source: org_study_id
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