Arteriovenous Fistula Maturation Evaluation Study. FAME Study

End-stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04736875
• Other study ID #: 3
• Status: Completed
• Start date: February 1, 2019
• Est. completion date: February 20, 2022

Study information

• Verified date: March 2022
• Source: Medifil AE
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: February 20, 2022
• Est. primary completion date: February 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Greece	Mediterranean Hospital	Glyfáda	Attiki

Sponsors (3)

Lead Sponsor	Collaborator
Medifil AE	Democritus University of Thrace, National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume flow	Volume of flow in brachial artery in L/min	day 1 post access creation
Primary	Volume flow	Volume of flow in brachial artery in L/min	day 2 post access creation
Primary	Volume flow	Volume of flow in brachial artery in L/min	day 3 post access creation
Primary	Volume flow	Volume of flow in brachial artery in L/min	day 4 post access creation
Primary	Volume flow	Volume of flow in brachial artery in L/min	day 5 post access creation
Primary	Volume flow	Volume of flow in brachial artery in L/min	day 6 post access creation
Primary	Volume flow	Volume of flow in brachial artery in L/min	day 7 post access creation
Primary	Volume flow	Volume of flow in brachial artery in L/min	day 14 post access creation
Primary	Volume flow	Volume of flow in brachial artery in L/min	day 21 post access creation
Primary	Volume flow	Volume of flow in brachial artery in L/min	day 28 post access creation
Primary	Volume flow	Volume of flow in brachial artery in L/min	day 60 post access creation
Primary	Volume flow	Volume of flow in brachial artery in L/min	day 90 post access creation
Primary	brachial artery diameter	Diameter of the Brachial artery in mm	day 1 post access creation
Primary	brachial artery diameter	Diameter of the Brachial artery in mm	day 2 post access creation
Primary	brachial artery diameter	Diameter of the Brachial artery in mm	day 3 post access creation
Primary	brachial artery diameter	Diameter of the Brachial artery in mm	day 4 post access creation
Primary	brachial artery diameter	Diameter of the Brachial artery in mm	day 5 post access creation
Primary	brachial artery diameter	Diameter of the Brachial artery in mm	day 6 post access creation
Primary	brachial artery diameter	Diameter of the Brachial artery in mm	day 7 post access creation
Primary	brachial artery diameter	Diameter of the Brachial artery in mm	day 14 post access creation
Primary	brachial artery diameter	Diameter of the Brachial artery in mm	day 21 post access creation
Primary	brachial artery diameter	Diameter of the Brachial artery in mm	day 28 post access creation
Primary	brachial artery diameter	Diameter of the Brachial artery in mm	day 60 post access creation
Primary	brachial artery diameter	Diameter of the Brachial artery in mm	day 90 post access creation
Primary	Resistive index RI	Calculation of the Resistive Index of the Brachial artery	day 1 post access creation
Primary	Resistive index RI	Calculation of the Resistive Index of the Brachial artery	day 2 post access creation
Primary	Resistive index RI	Calculation of the Resistive Index of the Brachial artery	day 3 post access creation
Primary	Resistive index RI	Calculation of the Resistive Index of the Brachial artery	day 4 post access creation
Primary	Resistive index RI	Calculation of the Resistive Index of the Brachial artery	day 5 post access creation
Primary	Resistive index RI	Calculation of the Resistive Index of the Brachial artery	day 6 post access creation
Primary	Resistive index RI	Calculation of the Resistive Index of the Brachial artery	day 7 post access creation
Primary	Resistive index RI	Calculation of the Resistive Index of the Brachial artery	day 14 post access creation
Primary	Resistive index RI	Calculation of the Resistive Index of the Brachial artery	day 21 post access creation
Primary	Resistive index RI	Calculation of the Resistive Index of the Brachial artery	day 28 post access creation
Primary	Resistive index RI	Calculation of the Resistive Index of the Brachial artery	day 60 post access creation
Primary	Resistive index RI	Calculation of the Resistive Index of the Brachial artery	day 90 post access creation
Primary	Diameter of the efferent vein	Diameter of the the efferent vein in mm	day 1 post access creation
Primary	Diameter of the efferent vein	Diameter of the the efferent vein in mm	day 2 post access creation
Primary	Diameter of the efferent vein	Diameter of the the efferent vein in mm	day 3 post access creation
Primary	Diameter of the efferent vein	Diameter of the the efferent vein in mm	day 4 post access creation
Primary	Diameter of the efferent vein	Diameter of the the efferent vein in mm	day 5 post access creation
Primary	Diameter of the efferent vein	Diameter of the the efferent vein in mm	day 6 post access creation
Primary	Diameter of the efferent vein	Diameter of the the efferent vein in mm	day 7 post access creation
Primary	Diameter of the efferent vein	Diameter of the the efferent vein in mm	day 14 post access creation
Primary	Diameter of the efferent vein	Diameter of the the efferent vein in mm	day 21 post access creation
Primary	Diameter of the efferent vein	Diameter of the the efferent vein in mm	day 28 post access creation
Primary	Diameter of the efferent vein	Diameter of the the efferent vein in mm	day 60 post access creation
Primary	Diameter of the efferent vein	Diameter of the the efferent vein in mm	day 90 post access creation
Primary	Wall thickness of the efferent vein	Wall thickness of the efferent vein in mm	day 1 post access creation
Primary	Wall thickness of the efferent vein	Wall thickness of the efferent vein in mm	day 2 post access creation
Primary	Wall thickness of the efferent vein	Wall thickness of the efferent vein in mm	day 3 post access creation
Primary	Wall thickness of the efferent vein	Wall thickness of the efferent vein in mm	day 4 post access creation
Primary	Wall thickness of the efferent vein	Wall thickness of the efferent vein in mm	day 5 post access creation
Primary	Wall thickness of the efferent vein	Wall thickness of the efferent vein in mm	day 6 post access creation
Primary	Wall thickness of the efferent vein	Wall thickness of the efferent vein in mm	day 7 post access creation
Primary	Wall thickness of the efferent vein	Wall thickness of the efferent vein in mm	day 14 post access creation
Primary	Wall thickness of the efferent vein	Wall thickness of the efferent vein in mm	day 21 post access creation
Primary	Wall thickness of the efferent vein	Wall thickness of the efferent vein in mm	day 28 post access creation
Primary	Wall thickness of the efferent vein	Wall thickness of the efferent vein in mm	day 60 post access creation
Primary	Wall thickness of the efferent vein	Wall thickness of the efferent vein in mm	day 90 post access creation
Secondary	Time of first successful cannulation	Time period between access creation and first successful cannulation for hemodialysis	30 and 60 days
Secondary	Successful hemodialysis	Three consecutive adequate hemodialysis sessions based on measurement of single pool kt/V	30 and 60 days
Secondary	Primary patency	Percentage of total patent arteriovenous fistulae without the need of additional interventions assessed by transcutaneous dopler ultrasound	6 months
Secondary	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)