Arteriovenous Fistula Maturation Evaluation Study. FAME Study

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

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

Study Overview

• Status: Completed
• Conditions: Hemodialysis Access Failure; End-stage Renal Disease; Native Arteriovenous Fistula; Vascular Access Maturation
• Intervention / Treatment: Diagnostic test: Doppler ultrasound study

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 Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• Greece
  • Attiki
    • Glyfáda, Attiki, Greece, 16675
      • Mediterranean Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study will recruit patients with end-stage renal disease eligible for native arteriovenous fistula creation for hemodialysis fulfilling the study's inclusion critera.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dialysis; Patients with hemodialysis-dependent end-stage renal disease and a newly created native arteriovenous fistula	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume flow	Volume of flow in brachial artery in L/min	day 1 post access creation
Volume flow	Volume of flow in brachial artery in L/min	day 2 post access creation
Volume flow	Volume of flow in brachial artery in L/min	day 3 post access creation
Volume flow	Volume of flow in brachial artery in L/min	day 4 post access creation
Volume flow	Volume of flow in brachial artery in L/min	day 5 post access creation
Volume flow	Volume of flow in brachial artery in L/min	day 6 post access creation
Volume flow	Volume of flow in brachial artery in L/min	day 7 post access creation
Volume flow	Volume of flow in brachial artery in L/min	day 14 post access creation
Volume flow	Volume of flow in brachial artery in L/min	day 21 post access creation
Volume flow	Volume of flow in brachial artery in L/min	day 28 post access creation
Volume flow	Volume of flow in brachial artery in L/min	day 60 post access creation
Volume flow	Volume of flow in brachial artery in L/min	day 90 post access creation
brachial artery diameter	Diameter of the Brachial artery in mm	day 1 post access creation
brachial artery diameter	Diameter of the Brachial artery in mm	day 2 post access creation
brachial artery diameter	Diameter of the Brachial artery in mm	day 3 post access creation
brachial artery diameter	Diameter of the Brachial artery in mm	day 4 post access creation
brachial artery diameter	Diameter of the Brachial artery in mm	day 5 post access creation
brachial artery diameter	Diameter of the Brachial artery in mm	day 6 post access creation
brachial artery diameter	Diameter of the Brachial artery in mm	day 7 post access creation
brachial artery diameter	Diameter of the Brachial artery in mm	day 14 post access creation
brachial artery diameter	Diameter of the Brachial artery in mm	day 21 post access creation
brachial artery diameter	Diameter of the Brachial artery in mm	day 28 post access creation
brachial artery diameter	Diameter of the Brachial artery in mm	day 60 post access creation
brachial artery diameter	Diameter of the Brachial artery in mm	day 90 post access creation
Resistive index RI	Calculation of the Resistive Index of the Brachial artery	day 1 post access creation
Resistive index RI	Calculation of the Resistive Index of the Brachial artery	day 2 post access creation
Resistive index RI	Calculation of the Resistive Index of the Brachial artery	day 3 post access creation
Resistive index RI	Calculation of the Resistive Index of the Brachial artery	day 4 post access creation
Resistive index RI	Calculation of the Resistive Index of the Brachial artery	day 5 post access creation
Resistive index RI	Calculation of the Resistive Index of the Brachial artery	day 6 post access creation
Resistive index RI	Calculation of the Resistive Index of the Brachial artery	day 7 post access creation
Resistive index RI	Calculation of the Resistive Index of the Brachial artery	day 14 post access creation
Resistive index RI	Calculation of the Resistive Index of the Brachial artery	day 21 post access creation
Resistive index RI	Calculation of the Resistive Index of the Brachial artery	day 28 post access creation
Resistive index RI	Calculation of the Resistive Index of the Brachial artery	day 60 post access creation
Resistive index RI	Calculation of the Resistive Index of the Brachial artery	day 90 post access creation
Diameter of the efferent vein	Diameter of the the efferent vein in mm	day 1 post access creation
Diameter of the efferent vein	Diameter of the the efferent vein in mm	day 2 post access creation
Diameter of the efferent vein	Diameter of the the efferent vein in mm	day 3 post access creation
Diameter of the efferent vein	Diameter of the the efferent vein in mm	day 4 post access creation
Diameter of the efferent vein	Diameter of the the efferent vein in mm	day 5 post access creation
Diameter of the efferent vein	Diameter of the the efferent vein in mm	day 6 post access creation
Diameter of the efferent vein	Diameter of the the efferent vein in mm	day 7 post access creation
Diameter of the efferent vein	Diameter of the the efferent vein in mm	day 14 post access creation
Diameter of the efferent vein	Diameter of the the efferent vein in mm	day 21 post access creation
Diameter of the efferent vein	Diameter of the the efferent vein in mm	day 28 post access creation
Diameter of the efferent vein	Diameter of the the efferent vein in mm	day 60 post access creation
Diameter of the efferent vein	Diameter of the the efferent vein in mm	day 90 post access creation
Wall thickness of the efferent vein	Wall thickness of the efferent vein in mm	day 1 post access creation
Wall thickness of the efferent vein	Wall thickness of the efferent vein in mm	day 2 post access creation
Wall thickness of the efferent vein	Wall thickness of the efferent vein in mm	day 3 post access creation
Wall thickness of the efferent vein	Wall thickness of the efferent vein in mm	day 4 post access creation
Wall thickness of the efferent vein	Wall thickness of the efferent vein in mm	day 5 post access creation
Wall thickness of the efferent vein	Wall thickness of the efferent vein in mm	day 6 post access creation
Wall thickness of the efferent vein	Wall thickness of the efferent vein in mm	day 7 post access creation
Wall thickness of the efferent vein	Wall thickness of the efferent vein in mm	day 14 post access creation
Wall thickness of the efferent vein	Wall thickness of the efferent vein in mm	day 21 post access creation
Wall thickness of the efferent vein	Wall thickness of the efferent vein in mm	day 28 post access creation
Wall thickness of the efferent vein	Wall thickness of the efferent vein in mm	day 60 post access creation
Wall thickness of the efferent vein	Wall thickness of the efferent vein in mm	day 90 post access creation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of first successful cannulation	Time period between access creation and first successful cannulation for hemodialysis	30 and 60 days
Successful hemodialysis	Three consecutive adequate hemodialysis sessions based on measurement of single pool kt/V	30 and 60 days
Primary patency	Percentage of total patent arteriovenous fistulae without the need of additional interventions assessed by transcutaneous dopler ultrasound	6 months
Surgeon-Nephrologist access site selection concordance	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	At access creation (day 0)

Collaborators and Investigators

• Sponsor: Medifil AE
• Collaborators: National and Kapodistrian University of Athens; Democritus University of Thrace
• Investigators: Principal Investigator: Ioannis E Giannikouris, MD, MSc, PhD, Mediterranean Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): February 20, 2022
• Study Completion (Actual): February 20, 2022

Study Registration Dates

• First Submitted: January 27, 2021
• First Submitted That Met QC Criteria: January 29, 2021
• First Posted (Actual): February 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 23, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: hemodialysis; maturation; native arteriovenous fistula; feeding artery; efferent vein
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Congenital Abnormalities; Renal Insufficiency; Pathological Conditions, Anatomical; Renal Insufficiency, Chronic; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Kidney Failure, Chronic; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: 3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No