Arteriovenous Fistula Maturation Evaluation Study. FAME Study

Completed

• Conditions: End-stage Renal Disease; Native Arteriovenous Fistula; Hemodialysis Access Failure; Vascular Access Maturation
• Interventions: Diagnostic Test: Doppler ultrasound study

• Registration Number: NCT04736875
• Lead Sponsor: Medifil AE

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.

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2021-01-27
• Study First Submitted QC: 2021-01-29
• Study First Posted: 2021-02-03
• Primary Completion: 2022-02-20
• Study Completion: 2022-02-20
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dialysis	Doppler ultrasound study	Patients with hemodialysis-dependent end-stage renal disease and a newly created native arteriovenous fistula

Primary Outcome Measures

Name	Time	Method
Resistive index RI	day 90 post access creation	Calculation of the Resistive Index of the Brachial artery
Diameter of the efferent vein	day 90 post access creation	Diameter of the the efferent vein in mm
Wall thickness of the efferent vein	day 90 post access creation	Wall thickness of the efferent vein in mm
brachial artery diameter	day 90 post access creation	Diameter of the Brachial artery in mm
Volume flow	day 90 post access creation	Volume of flow in brachial artery in L/min

Secondary Outcome Measures

Name	Time	Method
Time of first successful cannulation	30 and 60 days	Time period between access creation and first successful cannulation for hemodialysis
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
Successful hemodialysis	30 and 60 days	Three consecutive adequate hemodialysis sessions based on measurement of single pool kt/V

Trial Locations

Locations (1)

Mediterranean Hospital; 🇬🇷 Glyfáda, Attiki, Greece