Arteriovenous Fistula Maturation Evaluation Study. FAME Study

NCT ID: NCT04736875

Last Updated: 2022-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

86 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-01

Study Completion Date

2022-02-20

Brief Summary

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

Detailed Description

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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

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Dialysis

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

Doppler ultrasound study

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National and Kapodistrian University of Athens

OTHER

Sponsor Role collaborator

Democritus University of Thrace

OTHER

Sponsor Role collaborator

Medifil AE

OTHER

Sponsor Role lead

Responsible Party

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Ioannis Emmanouel Giannikouris

Director Nephrologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ioannis E Giannikouris, MD, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Mediterranean Hospital

Locations

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Mediterranean Hospital

Glyfada, Attica, Greece

Site Status

Countries

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Greece

Other Identifiers

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3

Identifier Type: -

Identifier Source: org_study_id

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