End-stage Renal Disease, Hemodialysis Access Failure, Native Arteriovenous Fistula, Vascular Access Maturation
Conditions
Keywords
hemodialysis, native arteriovenous fistula, maturation, feeding artery, efferent vein
Brief summary
Study of the features of hemodynamic and clinical maturation of the native arteriovenous fistula for hemodialysis.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTDoppler ultrasound study
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.
Sponsors
National and Kapodistrian University of Athens
Democritus University of Thrace
Medifil AE
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
1. Hemodialysis patients 2. new native arteriovenous fistula (AVF)
Exclusion criteria
1. Patients not eligible for AVF creation 2. Patients with non compensated heart failure New York Heart Association stages 3 and 4
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wall thickness of the efferent vein | day 1 post access creation | Wall thickness of the efferent vein in mm |
| Volume flow | day 1 post access creation | Volume of flow in brachial artery in L/min |
| brachial artery diameter | day 1 post access creation | Diameter of the Brachial artery in mm |
| Resistive index RI | day 1 post access creation | Calculation of the Resistive Index of the Brachial artery |
| Diameter of the efferent vein | day 1 post access creation | Diameter of the the efferent vein in mm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful hemodialysis | 30 and 60 days | Three consecutive adequate hemodialysis sessions based on measurement of single pool kt/V |
| Primary patency | 6 months | Percentage of total patent arteriovenous fistulae without the need of additional interventions assessed by transcutaneous dopler ultrasound |
| Surgeon-Nephrologist access site selection concordance | At access creation (day 0) | 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 |
| Time of first successful cannulation | 30 and 60 days | Time period between access creation and first successful cannulation for hemodialysis |
Countries
Greece
Outcome results
None listed