Clinical trial NCT04736875: Arteriovenous Fistula Maturation Evaluation Study. FAME Study
Official title: Study of the Hemodynamic and Clinical Maturation of the Native Arteriovenous Fistula for Hemodialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End-stage Renal Disease
Hemodialysis Access Failure
Vascular Access Maturation
Native Arteriovenous Fistula
Keywords: hemodialysis
native arteriovenous fistula
maturation
feeding artery
efferent vein
Lead sponsor: Medifil AE
Sponsor class: OTHER
Collaborators: name: National and Kapodistrian University of Athens
name: Democritus University of Thrace
First posted: 2021-02-03
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Volume flow
timeFrame: day 1 post access creation
measure: Volume flow
timeFrame: day 2 post access creation
measure: Volume flow
timeFrame: day 3 post access creation
measure: Volume flow
timeFrame: day 4 post access creation
measure: Volume flow
timeFrame: day 5 post access creation
measure: Volume flow
timeFrame: day 6 post access creation
measure: Volume flow
timeFrame: day 7 post access creation
measure: Volume flow
timeFrame: day 14 post access creation
measure: Volume flow
timeFrame: day 21 post access creation
measure: Volume flow
timeFrame: day 28 post access creation
measure: Volume flow
timeFrame: day 60 post access creation
measure: Volume flow
timeFrame: day 90 post access creation
measure: brachial artery diameter
timeFrame: day 1 post access creation
measure: brachial artery diameter
timeFrame: day 2 post access creation
measure: brachial artery diameter
timeFrame: day 3 post access creation
measure: brachial artery diameter
timeFrame: day 4 post access creation
measure: brachial artery diameter
timeFrame: day 5 post access creation
measure: brachial artery diameter
timeFrame: day 6 post access creation
measure: brachial artery diameter
timeFrame: day 7 post access creation
measure: brachial artery diameter
timeFrame: day 14 post access creation
measure: brachial artery diameter
timeFrame: day 21 post access creation
measure: brachial artery diameter
timeFrame: day 28 post access creation
measure: brachial artery diameter
timeFrame: day 60 post access creation
measure: brachial artery diameter
timeFrame: day 90 post access creation
measure: Resistive index RI
timeFrame: day 1 post access creation
measure: Resistive index RI
timeFrame: day 2 post access creation
measure: Resistive index RI
timeFrame: day 3 post access creation
measure: Resistive index RI
timeFrame: day 4 post access creation
measure: Resistive index RI
timeFrame: day 5 post access creation
measure: Resistive index RI
timeFrame: day 6 post access creation
measure: Resistive index RI
timeFrame: day 7 post access creation
measure: Resistive index RI
timeFrame: day 14 post access creation
measure: Resistive index RI
timeFrame: day 21 post access creation
measure: Resistive index RI
timeFrame: day 28 post access creation
measure: Resistive index RI
timeFrame: day 60 post access creation
measure: Resistive index RI
timeFrame: day 90 post access creation
measure: Diameter of the efferent vein
timeFrame: day 1 post access creation
measure: Diameter of the efferent vein
timeFrame: day 2 post access creation
measure: Diameter of the efferent vein
timeFrame: day 3 post access creation
measure: Diameter of the efferent vein
timeFrame: day 4 post access creation
measure: Diameter of the efferent vein
timeFrame: day 5 post access creation
measure: Diameter of the efferent vein
timeFrame: day 6 post access creation
measure: Diameter of the efferent vein
timeFrame: day 7 post access creation
measure: Diameter of the efferent vein
timeFrame: day 14 post access creation
measure: Diameter of the efferent vein
timeFrame: day 21 post access creation
measure: Diameter of the efferent vein
timeFrame: day 28 post access creation
measure: Diameter of the efferent vein
timeFrame: day 60 post access creation
measure: Diameter of the efferent vein
timeFrame: day 90 post access creation
measure: Wall thickness of the efferent vein
timeFrame: day 1 post access creation
measure: Wall thickness of the efferent vein
timeFrame: day 2 post access creation
measure: Wall thickness of the efferent vein
timeFrame: day 3 post access creation
measure: Wall thickness of the efferent vein
timeFrame: day 4 post access creation
measure: Wall thickness of the efferent vein
timeFrame: day 5 post access creation
measure: Wall thickness of the efferent vein
timeFrame: day 6 post access creation
measure: Wall thickness of the efferent vein
timeFrame: day 7 post access creation
measure: Wall thickness of the efferent vein
timeFrame: day 14 post access creation
measure: Wall thickness of the efferent vein
timeFrame: day 21 post access creation
measure: Wall thickness of the efferent vein
timeFrame: day 28 post access creation
measure: Wall thickness of the efferent vein
timeFrame: day 60 post access creation
measure: Wall thickness of the efferent vein
timeFrame: day 90 post access creation
Secondary outcomes:
measure: Time of first successful cannulation
timeFrame: 30 and 60 days
measure: Successful hemodialysis
timeFrame: 30 and 60 days
measure: Primary patency
timeFrame: 6 months
measure: Surgeon-Nephrologist access site selection concordance
timeFrame: At access creation (day 0)
Other outcomes:
Locations:
city: Glyfáda
country: Greece
facility: Mediterranean Hospital
state: Attiki
Study officials:
affiliation: Mediterranean Hospital
name: Ioannis E Giannikouris, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: