Arteriovenous Fistula Maturation Evaluation Study. FAME Study

March 8, 2022 updated by: Ioannis Emmanouel Giannikouris, Medifil AE

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Volume flow
Time Frame: day 1 post access creation
Volume of flow in brachial artery in L/min
day 1 post access creation
Volume flow
Time Frame: day 2 post access creation
Volume of flow in brachial artery in L/min
day 2 post access creation
Volume flow
Time Frame: day 3 post access creation
Volume of flow in brachial artery in L/min
day 3 post access creation
Volume flow
Time Frame: day 4 post access creation
Volume of flow in brachial artery in L/min
day 4 post access creation
Volume flow
Time Frame: day 5 post access creation
Volume of flow in brachial artery in L/min
day 5 post access creation
Volume flow
Time Frame: day 6 post access creation
Volume of flow in brachial artery in L/min
day 6 post access creation
Volume flow
Time Frame: day 7 post access creation
Volume of flow in brachial artery in L/min
day 7 post access creation
Volume flow
Time Frame: day 14 post access creation
Volume of flow in brachial artery in L/min
day 14 post access creation
Volume flow
Time Frame: day 21 post access creation
Volume of flow in brachial artery in L/min
day 21 post access creation
Volume flow
Time Frame: day 28 post access creation
Volume of flow in brachial artery in L/min
day 28 post access creation
Volume flow
Time Frame: day 60 post access creation
Volume of flow in brachial artery in L/min
day 60 post access creation
Volume flow
Time Frame: day 90 post access creation
Volume of flow in brachial artery in L/min
day 90 post access creation
brachial artery diameter
Time Frame: day 1 post access creation
Diameter of the Brachial artery in mm
day 1 post access creation
brachial artery diameter
Time Frame: day 2 post access creation
Diameter of the Brachial artery in mm
day 2 post access creation
brachial artery diameter
Time Frame: day 3 post access creation
Diameter of the Brachial artery in mm
day 3 post access creation
brachial artery diameter
Time Frame: day 4 post access creation
Diameter of the Brachial artery in mm
day 4 post access creation
brachial artery diameter
Time Frame: day 5 post access creation
Diameter of the Brachial artery in mm
day 5 post access creation
brachial artery diameter
Time Frame: day 6 post access creation
Diameter of the Brachial artery in mm
day 6 post access creation
brachial artery diameter
Time Frame: day 7 post access creation
Diameter of the Brachial artery in mm
day 7 post access creation
brachial artery diameter
Time Frame: day 14 post access creation
Diameter of the Brachial artery in mm
day 14 post access creation
brachial artery diameter
Time Frame: day 21 post access creation
Diameter of the Brachial artery in mm
day 21 post access creation
brachial artery diameter
Time Frame: day 28 post access creation
Diameter of the Brachial artery in mm
day 28 post access creation
brachial artery diameter
Time Frame: day 60 post access creation
Diameter of the Brachial artery in mm
day 60 post access creation
brachial artery diameter
Time Frame: day 90 post access creation
Diameter of the Brachial artery in mm
day 90 post access creation
Resistive index RI
Time Frame: day 1 post access creation
Calculation of the Resistive Index of the Brachial artery
day 1 post access creation
Resistive index RI
Time Frame: day 2 post access creation
Calculation of the Resistive Index of the Brachial artery
day 2 post access creation
Resistive index RI
Time Frame: day 3 post access creation
Calculation of the Resistive Index of the Brachial artery
day 3 post access creation
Resistive index RI
Time Frame: day 4 post access creation
Calculation of the Resistive Index of the Brachial artery
day 4 post access creation
Resistive index RI
Time Frame: day 5 post access creation
Calculation of the Resistive Index of the Brachial artery
day 5 post access creation
Resistive index RI
Time Frame: day 6 post access creation
Calculation of the Resistive Index of the Brachial artery
day 6 post access creation
Resistive index RI
Time Frame: day 7 post access creation
Calculation of the Resistive Index of the Brachial artery
day 7 post access creation
Resistive index RI
Time Frame: day 14 post access creation
Calculation of the Resistive Index of the Brachial artery
day 14 post access creation
Resistive index RI
Time Frame: day 21 post access creation
Calculation of the Resistive Index of the Brachial artery
day 21 post access creation
Resistive index RI
Time Frame: day 28 post access creation
Calculation of the Resistive Index of the Brachial artery
day 28 post access creation
Resistive index RI
Time Frame: day 60 post access creation
Calculation of the Resistive Index of the Brachial artery
day 60 post access creation
Resistive index RI
Time Frame: day 90 post access creation
Calculation of the Resistive Index of the Brachial artery
day 90 post access creation
Diameter of the efferent vein
Time Frame: day 1 post access creation
Diameter of the the efferent vein in mm
day 1 post access creation
Diameter of the efferent vein
Time Frame: day 2 post access creation
Diameter of the the efferent vein in mm
day 2 post access creation
Diameter of the efferent vein
Time Frame: day 3 post access creation
Diameter of the the efferent vein in mm
day 3 post access creation
Diameter of the efferent vein
Time Frame: day 4 post access creation
Diameter of the the efferent vein in mm
day 4 post access creation
Diameter of the efferent vein
Time Frame: day 5 post access creation
Diameter of the the efferent vein in mm
day 5 post access creation
Diameter of the efferent vein
Time Frame: day 6 post access creation
Diameter of the the efferent vein in mm
day 6 post access creation
Diameter of the efferent vein
Time Frame: day 7 post access creation
Diameter of the the efferent vein in mm
day 7 post access creation
Diameter of the efferent vein
Time Frame: day 14 post access creation
Diameter of the the efferent vein in mm
day 14 post access creation
Diameter of the efferent vein
Time Frame: day 21 post access creation
Diameter of the the efferent vein in mm
day 21 post access creation
Diameter of the efferent vein
Time Frame: day 28 post access creation
Diameter of the the efferent vein in mm
day 28 post access creation
Diameter of the efferent vein
Time Frame: day 60 post access creation
Diameter of the the efferent vein in mm
day 60 post access creation
Diameter of the efferent vein
Time Frame: day 90 post access creation
Diameter of the the efferent vein in mm
day 90 post access creation
Wall thickness of the efferent vein
Time Frame: day 1 post access creation
Wall thickness of the efferent vein in mm
day 1 post access creation
Wall thickness of the efferent vein
Time Frame: day 2 post access creation
Wall thickness of the efferent vein in mm
day 2 post access creation
Wall thickness of the efferent vein
Time Frame: day 3 post access creation
Wall thickness of the efferent vein in mm
day 3 post access creation
Wall thickness of the efferent vein
Time Frame: day 4 post access creation
Wall thickness of the efferent vein in mm
day 4 post access creation
Wall thickness of the efferent vein
Time Frame: day 5 post access creation
Wall thickness of the efferent vein in mm
day 5 post access creation
Wall thickness of the efferent vein
Time Frame: day 6 post access creation
Wall thickness of the efferent vein in mm
day 6 post access creation
Wall thickness of the efferent vein
Time Frame: day 7 post access creation
Wall thickness of the efferent vein in mm
day 7 post access creation
Wall thickness of the efferent vein
Time Frame: day 14 post access creation
Wall thickness of the efferent vein in mm
day 14 post access creation
Wall thickness of the efferent vein
Time Frame: day 21 post access creation
Wall thickness of the efferent vein in mm
day 21 post access creation
Wall thickness of the efferent vein
Time Frame: day 28 post access creation
Wall thickness of the efferent vein in mm
day 28 post access creation
Wall thickness of the efferent vein
Time Frame: day 60 post access creation
Wall thickness of the efferent vein in mm
day 60 post access creation
Wall thickness of the efferent vein
Time Frame: day 90 post access creation
Wall thickness of the efferent vein in mm
day 90 post access creation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time of first successful cannulation
Time Frame: 30 and 60 days
Time period between access creation and first successful cannulation for hemodialysis
30 and 60 days
Successful hemodialysis
Time Frame: 30 and 60 days
Three consecutive adequate hemodialysis sessions based on measurement of single pool kt/V
30 and 60 days
Primary patency
Time Frame: 6 months
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
Time Frame: At access creation (day 0)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medifil AE

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National and Kapodistrian University of Athens
Democritus University of Thrace

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ioannis E Giannikouris, MD, MSc, PhD, Mediterranean Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 20, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 20, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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