Arteriovenous Fistula Maturation Evaluation Study. FAME Study

Study Overview
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Brief Summary
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Study of the features of hemodynamic and clinical maturation of the native arteriovenous fistula for hemodialysis.

Detailed Description
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This is a prospective, single-center, observational study, investigating the clinical and hemodynamic features of maturation of hemodialysis native arteriovenous fistula (AVF). Hemodynamic features under investigation are the diameter of the feeding brachial artery, volume of flow (VF) measured with transcutaneous Duplex ultrasound (DUS), resistivity index (RI), diameter and wall thickness of the efferent vein, measured at days 1, 2, 3, 4, 5, 6, 7, 14, 21, 30, 60 and 90 post creation. Clinical features of maturation are the time of first access successful cannulation and the performance of three consecutive adequate dialysis sessions.

Official Title
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Study of the Hemodynamic and Clinical Maturation of the Native Arteriovenous Fistula for Hemodialysis

Conditions
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End-stage Renal Disease, Hemodialysis Access Failure, Vascular Access Maturation, Native Arteriovenous Fistula

Intervention / Treatment
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* Diagnostic Test: Doppler ultrasound study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hemodialysis patients new native arteriovenous fistula (AVF) Exclusion Criteria: Patients not eligible for AVF creation Patients with non compensated heart failure New York Heart Association stages 3 and 4

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dialysis<br>Patients with hemodialysis-dependent end-stage renal disease and a newly created native arteriovenous fistula | Diagnostic Test: Doppler ultrasound study<br>* Transcutaneous Doppler ultrasound (DUS) study was performed at the mid brachial artery to assess diameter, VF and RI, and at the mid segment of the efferent vein to assess the diameter and wall thickness.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume flow | Volume of flow in brachial artery in L/min | day 1 post access creation | 
| Volume flow | Volume of flow in brachial artery in L/min | day 2 post access creation | 
| Volume flow | Volume of flow in brachial artery in L/min | day 3 post access creation | 
| Volume flow | Volume of flow in brachial artery in L/min | day 4 post access creation | 
| Volume flow | Volume of flow in brachial artery in L/min | day 5 post access creation | 
| Volume flow | Volume of flow in brachial artery in L/min | day 6 post access creation | 
| Volume flow | Volume of flow in brachial artery in L/min | day 7 post access creation | 
| Volume flow | Volume of flow in brachial artery in L/min | day 14 post access creation | 
| Volume flow | Volume of flow in brachial artery in L/min | day 21 post access creation | 
| Volume flow | Volume of flow in brachial artery in L/min | day 28 post access creation | 
| Volume flow | Volume of flow in brachial artery in L/min | day 60 post access creation | 
| Volume flow | Volume of flow in brachial artery in L/min | day 90 post access creation | 
| brachial artery diameter | Diameter of the Brachial artery in mm | day 1 post access creation | 
| brachial artery diameter | Diameter of the Brachial artery in mm | day 2 post access creation | 
| brachial artery diameter | Diameter of the Brachial artery in mm | day 3 post access creation | 
| brachial artery diameter | Diameter of the Brachial artery in mm | day 4 post access creation | 
| brachial artery diameter | Diameter of the Brachial artery in mm | day 5 post access creation | 
| brachial artery diameter | Diameter of the Brachial artery in mm | day 6 post access creation | 
| brachial artery diameter | Diameter of the Brachial artery in mm | day 7 post access creation | 
| brachial artery diameter | Diameter of the Brachial artery in mm | day 14 post access creation | 
| brachial artery diameter | Diameter of the Brachial artery in mm | day 21 post access creation | 
| brachial artery diameter | Diameter of the Brachial artery in mm | day 28 post access creation | 
| brachial artery diameter | Diameter of the Brachial artery in mm | day 60 post access creation | 
| brachial artery diameter | Diameter of the Brachial artery in mm | day 90 post access creation | 
| Resistive index RI | Calculation of the Resistive Index of the Brachial artery | day 1 post access creation | 
| Resistive index RI | Calculation of the Resistive Index of the Brachial artery | day 2 post access creation | 
| Resistive index RI | Calculation of the Resistive Index of the Brachial artery | day 3 post access creation | 
| Resistive index RI | Calculation of the Resistive Index of the Brachial artery | day 4 post access creation | 
| Resistive index RI | Calculation of the Resistive Index of the Brachial artery | day 5 post access creation | 
| Resistive index RI | Calculation of the Resistive Index of the Brachial artery | day 6 post access creation | 
| Resistive index RI | Calculation of the Resistive Index of the Brachial artery | day 7 post access creation | 
| Resistive index RI | Calculation of the Resistive Index of the Brachial artery | day 14 post access creation | 
| Resistive index RI | Calculation of the Resistive Index of the Brachial artery | day 21 post access creation | 
| Resistive index RI | Calculation of the Resistive Index of the Brachial artery | day 28 post access creation | 
| Resistive index RI | Calculation of the Resistive Index of the Brachial artery | day 60 post access creation | 
| Resistive index RI | Calculation of the Resistive Index of the Brachial artery | day 90 post access creation | 
| Diameter of the efferent vein | Diameter of the the efferent vein in mm | day 1 post access creation | 
| Diameter of the efferent vein | Diameter of the the efferent vein in mm | day 2 post access creation | 
| Diameter of the efferent vein | Diameter of the the efferent vein in mm | day 3 post access creation | 
| Diameter of the efferent vein | Diameter of the the efferent vein in mm | day 4 post access creation | 
| Diameter of the efferent vein | Diameter of the the efferent vein in mm | day 5 post access creation | 
| Diameter of the efferent vein | Diameter of the the efferent vein in mm | day 6 post access creation | 
| Diameter of the efferent vein | Diameter of the the efferent vein in mm | day 7 post access creation | 
| Diameter of the efferent vein | Diameter of the the efferent vein in mm | day 14 post access creation | 
| Diameter of the efferent vein | Diameter of the the efferent vein in mm | day 21 post access creation | 
| Diameter of the efferent vein | Diameter of the the efferent vein in mm | day 28 post access creation | 
| Diameter of the efferent vein | Diameter of the the efferent vein in mm | day 60 post access creation | 
| Diameter of the efferent vein | Diameter of the the efferent vein in mm | day 90 post access creation | 
| Wall thickness of the efferent vein | Wall thickness of the efferent vein in mm | day 1 post access creation | 
| Wall thickness of the efferent vein | Wall thickness of the efferent vein in mm | day 2 post access creation | 
| Wall thickness of the efferent vein | Wall thickness of the efferent vein in mm | day 3 post access creation | 
| Wall thickness of the efferent vein | Wall thickness of the efferent vein in mm | day 4 post access creation | 
| Wall thickness of the efferent vein | Wall thickness of the efferent vein in mm | day 5 post access creation | 
| Wall thickness of the efferent vein | Wall thickness of the efferent vein in mm | day 6 post access creation | 
| Wall thickness of the efferent vein | Wall thickness of the efferent vein in mm | day 7 post access creation | 
| Wall thickness of the efferent vein | Wall thickness of the efferent vein in mm | day 14 post access creation | 
| Wall thickness of the efferent vein | Wall thickness of the efferent vein in mm | day 21 post access creation | 
| Wall thickness of the efferent vein | Wall thickness of the efferent vein in mm | day 28 post access creation | 
| Wall thickness of the efferent vein | Wall thickness of the efferent vein in mm | day 60 post access creation | 
| Wall thickness of the efferent vein | Wall thickness of the efferent vein in mm | day 90 post access creation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of first successful cannulation | Time period between access creation and first successful cannulation for hemodialysis | 30 and 60 days | 
| Successful hemodialysis | Three consecutive adequate hemodialysis sessions based on measurement of single pool kt/V | 30 and 60 days | 
| Primary patency | Percentage of total patent arteriovenous fistulae without the need of additional interventions assessed by transcutaneous dopler ultrasound | 6 months | 
| Surgeon-Nephrologist access site selection concordance | Record of the opinion regarding the site of vascular access creation between the nephrologist performing preoperative mapping and the surgeon performing access creation with the use of a questionaire | At access creation (day 0) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodialysis, native arteriovenous fistula, maturation, feeding artery, efferent vein