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Improving Arteriovenous Fistula Patency (METTRO)

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ClinicalTrials.gov Identifier: NCT02111655
Recruitment Status : Completed
First Posted : April 11, 2014
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
Antonio Cirugeda, Hospital Infanta Sofia

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.


Condition or disease Intervention/treatment Phase
Thrombosis Device: Second generation surveillance of AVF Procedure: vital signs Procedure: physical examination of AVF Procedure: ktv test Procedure: urea method Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Second Generation Surveillance Techniques to Prevent Thrombosis and Increase Assisted Primary Patency in Native Arteriovenous Fistula. A Prospective Controlled Trial.
Study Start Date : September 1, 2012
Actual Primary Completion Date : September 29, 2015
Actual Study Completion Date : September 29, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Procedure: vital signs
Effective blood flow, venous pressure, arterial pressure, at the beginning and at the end of the dialysis session

Procedure: physical examination of AVF
Predialysis physical examination of AVF every dialysis session.

Procedure: 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

Procedure: urea method
Quarterly recirculation with urea method.

Experimental: 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.
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.

Other Names:
  • Doppler ultrasound: M-Turbo. Sonosite.
  • Transonic dilution method: Transonic System Inc HD-03

Procedure: vital signs
Effective blood flow, venous pressure, arterial pressure, at the beginning and at the end of the dialysis session

Procedure: physical examination of AVF
Predialysis physical examination of AVF every dialysis session.

Procedure: 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

Procedure: urea method
Quarterly recirculation with urea method.




Primary Outcome Measures :
  1. Improved primary patency rate in arteriovenous fistulae with the use of doppler ultrasound and transonic dilution 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).



Secondary Outcome Measures :
  1. 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 ]
  2. Evaluate the efficacy and efficiency of second generation methods [ 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.

  3. Reproducibility in Doppler ultrasound technique [ 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.

  4. Possible influence of different baseline items in the risk of thrombosis of native AVF [ 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

  5. 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 ]
  6. Evaluate the efficacy and efficiency of second generation methods [ 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.

  7. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02111655


Locations
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Spain
Hospital Universitario Infanta Sofia
San Sebastian de Los Reyes, Madrid, Spain, 28702
Centro de Diálisis Los Enebros
Madrid, Spain, 28007
Hospital Universitario Gregorio Marañon
Madrid, Spain, 28007
Dialcentro
Madrid, Spain, 28009
Clinica Fuensanta
Madrid, Spain, 28027
Sponsors and Collaborators
Hospital Infanta Sofia
Investigators
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Principal Investigator: ANTONIO CIRUGEDA, MD HOSPITAL UNIVERSITARIO INFANTA SOFIA
Study Chair: 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Antonio Cirugeda, Principal Investigator, Hospital Infanta Sofia
ClinicalTrials.gov Identifier: NCT02111655     History of Changes
Other Study ID Numbers: 210443-031132-261233
3598 ( Other Identifier: CEIC HOSPITAL UNIVERSITARIO DE LA PAZ )
First Posted: April 11, 2014    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Antonio Cirugeda, Hospital Infanta Sofia:
Thrombosis
Arteriovenous fistulae
Hemodialysis
Doppler ultrasound
Vascular access blood flow
Surveillance

Additional relevant MeSH terms:
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Vascular Malformations
Thrombosis
Fistula
Arteriovenous Fistula
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Arteriovenous Malformations
Cardiovascular Abnormalities
Vascular Fistula
Congenital Abnormalities