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Improving Arteriovenous Fistula Patency (METTRO)

Primary Purpose

Thrombosis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Second generation surveillance of AVF
vital signs
physical examination of AVF
ktv test
urea method
Sponsored by
Hospital Infanta Sofia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Thrombosis focused on measuring Thrombosis, Arteriovenous fistulae, Hemodialysis, Doppler ultrasound, Vascular access blood flow, Surveillance

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario Infanta Sofia
  • Centro de Diálisis Los Enebros
  • Hospital Universitario Gregorio Marañon
  • Dialcentro
  • Clinica Fuensanta

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Clasical Surveillance of AVF

Second generation surveillance of AVF

Arm Description

Classical evaluation of AVF includes: Vital sings and predialysis physical examination of AVF every dialysis session. Effective blood flow, venous pressure, arterial pressure, at the beginning and at the end of the dialysis session. Weekly ktv test using biosensors or monthly if using monocompartimental Daugirdas equation. 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.

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: 25% or higher decreased in QA compared with previous measurement. QA lower than 500 ml/min. 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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Compared non-assisted primary patency rates (intervention free access survival) and secondary patency rates (access survival until abandonment) between the two groups.
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.
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.
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
Compared non-assisted primary patency rates (intervention free access survival) and secondary patency rates (access survival until abandonment) between the two groups.
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.
Compared non-assisted primary patency rates (intervention free access survival) and secondary patency rates (access survival until abandonment) between the two groups.

Full Information

First Posted
March 28, 2014
Last Updated
June 17, 2017
Sponsor
Hospital Infanta Sofia
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1. Study Identification

Unique Protocol Identification Number
NCT02111655
Brief Title
Improving Arteriovenous Fistula Patency
Acronym
METTRO
Official Title
Second Generation Surveillance Techniques to Prevent Thrombosis and Increase Assisted Primary Patency in Native Arteriovenous Fistula. A Prospective Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
September 1, 2012 (undefined)
Primary Completion Date
September 29, 2015 (Actual)
Study Completion Date
September 29, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Infanta Sofia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis
Keywords
Thrombosis, Arteriovenous fistulae, Hemodialysis, Doppler ultrasound, Vascular access blood flow, Surveillance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
212 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clasical Surveillance of AVF
Arm Type
Other
Arm Description
Classical evaluation of AVF includes: Vital sings and predialysis physical examination of AVF every dialysis session. Effective blood flow, venous pressure, arterial pressure, at the beginning and at the end of the dialysis session. Weekly ktv test using biosensors or monthly if using monocompartimental Daugirdas equation. 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.
Arm Title
Second generation surveillance of AVF
Arm Type
Experimental
Arm Description
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: 25% or higher decreased in QA compared with previous measurement. QA lower than 500 ml/min. 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.
Intervention Type
Device
Intervention Name(s)
Second generation surveillance of AVF
Other Intervention Name(s)
Doppler ultrasound: M-Turbo. Sonosite., Transonic dilution method: Transonic System Inc HD-03
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
vital signs
Intervention Description
Effective blood flow, venous pressure, arterial pressure, at the beginning and at the end of the dialysis session
Intervention Type
Procedure
Intervention Name(s)
physical examination of AVF
Intervention Description
Predialysis physical examination of AVF every dialysis session.
Intervention Type
Procedure
Intervention Name(s)
ktv test
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
urea method
Intervention Description
Quarterly recirculation with urea method.
Primary Outcome Measure Information:
Title
Improved primary patency rate in arteriovenous fistulae with the use of doppler ultrasound and transonic dilution method
Description
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 3 years follow up
Secondary Outcome Measure Information:
Title
Compared non-assisted primary patency rates (intervention free access survival) and secondary patency rates (access survival until abandonment) between the two groups.
Time Frame
Up to 1 year follow up
Title
Evaluate the efficacy and efficiency of second generation methods
Description
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 2 years follow up
Title
Reproducibility in Doppler ultrasound technique
Description
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.
Title
Possible influence of different baseline items in the risk of thrombosis of native AVF
Description
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 3 years follow up
Title
Compared non-assisted primary patency rates (intervention free access survival) and secondary patency rates (access survival until abandonment) between the two groups.
Time Frame
Up to 2 years follow up
Title
Evaluate the efficacy and efficiency of second generation methods
Description
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
Title
Compared non-assisted primary patency rates (intervention free access survival) and secondary patency rates (access survival until abandonment) between the two groups.
Time Frame
Up to 3 years follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ANTONIO CIRUGEDA, MD
Organizational Affiliation
HOSPITAL UNIVERSITARIO INFANTA SOFIA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
SILVIA CALDES, MD
Organizational Affiliation
HOSPITAL UNIVERSITARIO INFANTA SOFIA
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
YESIKA AMEZQUITA, MD
Organizational Affiliation
CLINICA FUENSANTA
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
JUAN MANUEL LOPEZ, PhD
Organizational Affiliation
HOSPITAL UNIVERSITARIO GREGORIO MARAÑON
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
SORAYA ABAD, MD
Organizational Affiliation
HOSPITAL UNIVERSITARIO GREGORIO MARAÑON
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
INES ARAGONCILLO, MD
Organizational Affiliation
Hospital Infanta Sofia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
BORJA QUIROGA, MD
Organizational Affiliation
HOSPITAL GREGORIO MARAÑON
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
FERNANDO DE ALVARO, PhD
Organizational Affiliation
Hospital Infanta Sofia
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Universitario Infanta Sofia
City
San Sebastian de Los Reyes
State/Province
Madrid
ZIP/Postal Code
28702
Country
Spain
Facility Name
Centro de Diálisis Los Enebros
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Dialcentro
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Clinica Fuensanta
City
Madrid
ZIP/Postal Code
28027
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28430315
Citation
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.
Results Reference
derived
PubMed Identifier
26391583
Citation
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.
Results Reference
derived

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Improving Arteriovenous Fistula Patency

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