Study of the Hemodynamic and Clinical Maturation of the Native Arteriovenous Fistula for Hemodialysis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- End-stage Renal Disease
- Sponsor
- Medifil AE
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Resistive index RI
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Ioannis Emmanouel Giannikouris
Director Nephrologist
Medifil AE
Eligibility Criteria
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
Outcomes
Primary Outcomes
Resistive index RI
Time Frame: day 90 post access creation
Calculation of the Resistive Index of the Brachial artery
Diameter of the efferent vein
Time Frame: day 90 post access creation
Diameter of the the efferent vein in mm
Wall thickness of the efferent vein
Time Frame: day 90 post access creation
Wall thickness of the efferent vein in mm
brachial artery diameter
Time Frame: day 90 post access creation
Diameter of the Brachial artery in mm
Volume flow
Time Frame: day 90 post access creation
Volume of flow in brachial artery in L/min
Secondary Outcomes
- Time of first successful cannulation(30 and 60 days)
- Primary patency(6 months)
- Surgeon-Nephrologist access site selection concordance(At access creation (day 0))
- Successful hemodialysis(30 and 60 days)