Improving Arteriovenous Fistula Patency

Thrombosis Clinical Trial

— METTRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02111655
• Other study ID #: 210443-031132-261233
• Secondary ID: 3598
• Status: Completed
• Phase: N/A
• First received: March 28, 2014
• Last updated: June 17, 2017
• Start date: September 1, 2012
• Est. completion date: September 29, 2015

Study information

• Verified date: June 2017
• Source: Hospital Infanta Sofia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: September 29, 2015
• Est. primary completion date: September 29, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• Informed consent signature.

• 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:

• Coagulopathy or hemoglobinopathy of any cause.

• Hospitalization of any cause in the previous month.

• VA related complications or dysfunction in the previous three months.

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Fistula
• Thrombosis

Intervention

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
• 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.

Locations

Country	Name	City	State
Spain	Centro de Diálisis Los Enebros	Madrid
Spain	Clinica Fuensanta	Madrid
Spain	Dialcentro	Madrid
Spain	Hospital Universitario Gregorio Marañon	Madrid
Spain	Hospital Universitario Infanta Sofia	San Sebastian de Los Reyes	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Infanta Sofia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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 2 years follow up
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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