NCT04736875

Arteriovenous Fistula Maturation Evaluation Study. FAME Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 86 (actual)
• Sponsor: Medifil AE · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Doppler 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.

Timeline

• Start date: 2019-02-01
• Primary completion: 2022-02-20
• Completion: 2022-02-20
• First posted: 2021-02-03
• Last updated: 2022-03-23

Locations

1 site across 1 country: Greece