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| ID | Type | Description | Link |
|---|---|---|---|
| 3598 | Other Identifier | CEIC HOSPITAL UNIVERSITARIO DE LA PAZ |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clasical Surveillance of AVF | Other | Classical evaluation of AVF includes:
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. |
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| Second generation surveillance of AVF | Experimental | 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Second generation surveillance of AVF | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Improved primary patency rate in arteriovenous fistulae with the use of doppler ultrasound and transonic dilution method | 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). | Up to 3 years follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Compared non-assisted primary patency rates (intervention free access survival) and secondary patency rates (access survival until abandonment) between the two groups. | Up to 1 year follow up | |
| Evaluate the efficacy and efficiency of second generation methods |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ANTONIO CIRUGEDA, MD | HOSPITAL UNIVERSITARIO INFANTA SOFIA | Principal Investigator |
| SILVIA CALDES, MD | HOSPITAL UNIVERSITARIO INFANTA SOFIA | Study Chair |
| YESIKA AMEZQUITA, MD | CLINICA FUENSANTA | Study Chair |
| JUAN MANUEL LOPEZ, PhD | HOSPITAL UNIVERSITARIO GREGORIO MARAÑON | Study Chair |
| SORAYA ABAD, MD | HOSPITAL UNIVERSITARIO GREGORIO MARAÑON | Study Chair |
| INES ARAGONCILLO, MD | Hospital Infanta Sofia | Study Chair |
| BORJA QUIROGA, MD | HOSPITAL GREGORIO MARAÑON | Study Chair |
| FERNANDO DE ALVARO, PhD | Hospital Infanta Sofia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Infanta Sofia | San Sebastián de los Reyes | Madrid | 28702 | Spain | ||
| Centro de Diálisis Los Enebros |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28430315 | Derived | 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. | |
| 26391583 |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| vital signs | Procedure | Effective blood flow, venous pressure, arterial pressure, at the beginning and at the end of the dialysis session |
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| physical examination of AVF | Procedure | Predialysis physical examination of AVF every dialysis session. |
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| ktv test | Procedure | 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 |
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| urea method | Procedure | Quarterly recirculation with urea method. |
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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.
| Up to 2 years follow up |
| Reproducibility in Doppler ultrasound technique | 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. | Up to 3 years follow up. |
| Possible influence of different baseline items in the risk of thrombosis of native AVF | 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 | Up to 3 years follow up |
| Compared non-assisted primary patency rates (intervention free access survival) and secondary patency rates (access survival until abandonment) between the two groups. | Up to 2 years follow up |
| Evaluate the efficacy and efficiency of second generation methods | 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. | Up to 3 years follow up |
| Compared non-assisted primary patency rates (intervention free access survival) and secondary patency rates (access survival until abandonment) between the two groups. | Up to 3 years follow up |
| Madrid |
| 28007 |
| Spain |
| Hospital Universitario Gregorio Marañon | Madrid | 28007 | Spain |
| Dialcentro | Madrid | 28009 | Spain |
| Clinica Fuensanta | Madrid | 28027 | Spain |
| Derived |
| 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. |