Arteriovenous Fistula Maturation Evaluation Study. FAME Study

Medifil AE

Status: Completed

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

Treatments: Diagnostic Test: Doppler ultrasound study

Study type: Observational

Funder types: Other

Identifiers

NCT04736875

3

Details and patient eligibility

About

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

Full 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.

Enrollment: 86 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

86 participants in 1 patient group

Dialysis

Description:

Patients with hemodialysis-dependent end-stage renal disease and a newly created native arteriovenous fistula

Treatment:

Diagnostic Test: Doppler ultrasound study