End-stage Renal DiseaseNCT04736875
Arteriovenous Fistula Maturation Evaluation Study. FAME Study
An observational study of End-stage Renal Disease and Hemodialysis Access Failure, run by Medifil AE at 1 site in Greece.
Trial summary
Study of the features of hemodynamic and clinical maturation of the native arteriovenous fistula for hemodialysis. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- End-stage Renal Disease, Hemodialysis Access Failure, Vascular Access Maturation
- What is being tested?
- Doppler ultrasound study
- How many people
- 86 participants
- Where
- 1 siteGreece
- Study dates
- 1 Feb 2019to 20 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Hemodialysis patients
- new native arteriovenous fistula (AVF)
Who cannot join
- Patients not eligible for AVF creation
- Patients with non compensated heart failure New York Heart Association stages 3 and 4
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- End-stage Renal Disease, Hemodialysis Access Failure, Vascular Access Maturation, Native Arteriovenous Fistula
- Being tested
- Doppler ultrasound study
- Keywords
- hemodialysis, native arteriovenous fistula, maturation, feeding artery, efferent vein
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler ultrasound studyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Dialysis | Patients with hemodialysis-dependent end-stage renal disease and a newly created native arteriovenous fistula Receives: Diagnostic Test: Doppler ultrasound study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume flow
Volume of flow in brachial artery in L/min
Measured: day 1 post access creation
Volume flow
Volume of flow in brachial artery in L/min
Measured: day 2 post access creation
Volume flow
Volume of flow in brachial artery in L/min
Measured: day 3 post access creation
Volume flow
Volume of flow in brachial artery in L/min
Measured: day 4 post access creation
Volume flow
Volume of flow in brachial artery in L/min
Measured: day 5 post access creation
Volume flow
Volume of flow in brachial artery in L/min
Measured: day 6 post access creation
Volume flow
Volume of flow in brachial artery in L/min
Measured: day 7 post access creation
Volume flow
Volume of flow in brachial artery in L/min
Measured: day 14 post access creation
Volume flow
Volume of flow in brachial artery in L/min
Measured: day 21 post access creation
Volume flow
Volume of flow in brachial artery in L/min
Measured: day 28 post access creation
Volume flow
Volume of flow in brachial artery in L/min
Measured: day 60 post access creation
Volume flow
Volume of flow in brachial artery in L/min
Measured: day 90 post access creation
brachial artery diameter
Diameter of the Brachial artery in mm
Measured: day 1 post access creation
brachial artery diameter
Diameter of the Brachial artery in mm
Measured: day 2 post access creation
brachial artery diameter
Diameter of the Brachial artery in mm
Measured: day 3 post access creation
brachial artery diameter
Diameter of the Brachial artery in mm
Measured: day 4 post access creation
brachial artery diameter
Diameter of the Brachial artery in mm
Measured: day 5 post access creation
brachial artery diameter
Diameter of the Brachial artery in mm
Measured: day 6 post access creation
brachial artery diameter
Diameter of the Brachial artery in mm
Measured: day 7 post access creation
brachial artery diameter
Diameter of the Brachial artery in mm
Measured: day 14 post access creation
brachial artery diameter
Diameter of the Brachial artery in mm
Measured: day 21 post access creation
brachial artery diameter
Diameter of the Brachial artery in mm
Measured: day 28 post access creation
brachial artery diameter
Diameter of the Brachial artery in mm
Measured: day 60 post access creation
brachial artery diameter
Diameter of the Brachial artery in mm
Measured: day 90 post access creation
Resistive index RI
Calculation of the Resistive Index of the Brachial artery
Measured: day 1 post access creation
Resistive index RI
Calculation of the Resistive Index of the Brachial artery
Measured: day 2 post access creation
Resistive index RI
Calculation of the Resistive Index of the Brachial artery
Measured: day 3 post access creation
Resistive index RI
Calculation of the Resistive Index of the Brachial artery
Measured: day 4 post access creation
Resistive index RI
Calculation of the Resistive Index of the Brachial artery
Measured: day 5 post access creation
Resistive index RI
Calculation of the Resistive Index of the Brachial artery
Measured: day 6 post access creation
Resistive index RI
Calculation of the Resistive Index of the Brachial artery
Measured: day 7 post access creation
Resistive index RI
Calculation of the Resistive Index of the Brachial artery
Measured: day 14 post access creation
Resistive index RI
Calculation of the Resistive Index of the Brachial artery
Measured: day 21 post access creation
Resistive index RI
Calculation of the Resistive Index of the Brachial artery
Measured: day 28 post access creation
Resistive index RI
Calculation of the Resistive Index of the Brachial artery
Measured: day 60 post access creation
Resistive index RI
Calculation of the Resistive Index of the Brachial artery
Measured: day 90 post access creation
Diameter of the efferent vein
Diameter of the the efferent vein in mm
Measured: day 1 post access creation
Diameter of the efferent vein
Diameter of the the efferent vein in mm
Measured: day 2 post access creation
Diameter of the efferent vein
Diameter of the the efferent vein in mm
Measured: day 3 post access creation
Diameter of the efferent vein
Diameter of the the efferent vein in mm
Measured: day 4 post access creation
Diameter of the efferent vein
Diameter of the the efferent vein in mm
Measured: day 5 post access creation
Diameter of the efferent vein
Diameter of the the efferent vein in mm
Measured: day 6 post access creation
Diameter of the efferent vein
Diameter of the the efferent vein in mm
Measured: day 7 post access creation
Diameter of the efferent vein
Diameter of the the efferent vein in mm
Measured: day 14 post access creation
Diameter of the efferent vein
Diameter of the the efferent vein in mm
Measured: day 21 post access creation
Diameter of the efferent vein
Diameter of the the efferent vein in mm
Measured: day 28 post access creation
Diameter of the efferent vein
Diameter of the the efferent vein in mm
Measured: day 60 post access creation
Diameter of the efferent vein
Diameter of the the efferent vein in mm
Measured: day 90 post access creation
Wall thickness of the efferent vein
Wall thickness of the efferent vein in mm
Measured: day 1 post access creation
Wall thickness of the efferent vein
Wall thickness of the efferent vein in mm
Measured: day 2 post access creation
Wall thickness of the efferent vein
Wall thickness of the efferent vein in mm
Measured: day 3 post access creation
Wall thickness of the efferent vein
Wall thickness of the efferent vein in mm
Measured: day 4 post access creation
Wall thickness of the efferent vein
Wall thickness of the efferent vein in mm
Measured: day 5 post access creation
Wall thickness of the efferent vein
Wall thickness of the efferent vein in mm
Measured: day 6 post access creation
Wall thickness of the efferent vein
Wall thickness of the efferent vein in mm
Measured: day 7 post access creation
Wall thickness of the efferent vein
Wall thickness of the efferent vein in mm
Measured: day 14 post access creation
Wall thickness of the efferent vein
Wall thickness of the efferent vein in mm
Measured: day 21 post access creation
Wall thickness of the efferent vein
Wall thickness of the efferent vein in mm
Measured: day 28 post access creation
Wall thickness of the efferent vein
Wall thickness of the efferent vein in mm
Measured: day 60 post access creation
Wall thickness of the efferent vein
Wall thickness of the efferent vein in mm
Measured: day 90 post access creation
Secondary outcomes (4)
Time of first successful cannulation
Time period between access creation and first successful cannulation for hemodialysis
Measured: 30 and 60 days
Successful hemodialysis
Three consecutive adequate hemodialysis sessions based on measurement of single pool kt/V
Measured: 30 and 60 days
Primary patency
Percentage of total patent arteriovenous fistulae without the need of additional interventions assessed by transcutaneous dopler ultrasound
Measured: 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
Measured: At access creation (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start1 Feb 2019
- Primary completion20 Feb 2022
- Study completion20 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medifil AE
- Sponsor type
- University, hospital or other
- Collaborators
- National and Kapodistrian University of Athens, Democritus University of Thrace
- Responsible party
- Principal investigator, Ioannis Emmanouel Giannikouris, Medifil AE
- Investigators
- Ioannis E Giannikouris, MD, MSc, PhD, Principal investigator, Mediterranean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736875
- Sponsor's protocol ID
- 3
- Status last verified
- Mar 2022
- First submitted
- 27 Jan 2021
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Hemodynamic and Clinical Maturation of the Native Arteriovenous Fistula for Hemodialysis
- ClinicalTrials.gov ID
- NCT04736875
- Acronym / sponsor ID
- 3
- Conditions
- End-stage Renal Disease, Hemodialysis Access Failure, Vascular Access Maturation, Native Arteriovenous Fistula
- Keywords
- hemodialysis, native arteriovenous fistula, maturation, feeding artery, efferent vein
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Medifil AEUniversity, hospital or other
- Collaborators
- National and Kapodistrian University of Athens, Democritus University of Thrace
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 20 Feb 2022 (actual)
- Study completion
- 20 Feb 2022 (actual)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dialysis | – | Diagnostic Test: Doppler ultrasound studyPatients with hemodialysis-dependent end-stage renal disease and a newly created native arteriovenous fistula |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Hemodialysis patients
- new native arteriovenous fistula (AVF)
Key exclusion criteria (2 listed)
- Patients not eligible for AVF creation
- Patients with non compensated heart failure New York Heart Association stages 3 and 4
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doppler ultrasound studyTranscutaneous 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. | Diagnostic test | Dialysis |
Primary outcome
Volume flow
Time frame: day 1 post access creation
Volume of flow in brachial artery in L/min
Volume flow
Time frame: day 2 post access creation
Volume of flow in brachial artery in L/min
Volume flow
Time frame: day 3 post access creation
Volume of flow in brachial artery in L/min
Volume flow
Time frame: day 4 post access creation
Volume of flow in brachial artery in L/min
Volume flow
Time frame: day 5 post access creation
Volume of flow in brachial artery in L/min
Volume flow
Time frame: day 6 post access creation
Volume of flow in brachial artery in L/min
Volume flow
Time frame: day 7 post access creation
Volume of flow in brachial artery in L/min
Volume flow
Time frame: day 14 post access creation
Volume of flow in brachial artery in L/min
Volume flow
Time frame: day 21 post access creation
Volume of flow in brachial artery in L/min
Volume flow
Time frame: day 28 post access creation
Volume of flow in brachial artery in L/min
Volume flow
Time frame: day 60 post access creation
Volume of flow in brachial artery in L/min
Volume flow
Time frame: day 90 post access creation
Volume of flow in brachial artery in L/min
brachial artery diameter
Time frame: day 1 post access creation
Diameter of the Brachial artery in mm
brachial artery diameter
Time frame: day 2 post access creation
Diameter of the Brachial artery in mm
brachial artery diameter
Time frame: day 3 post access creation
Diameter of the Brachial artery in mm
brachial artery diameter
Time frame: day 4 post access creation
Diameter of the Brachial artery in mm
brachial artery diameter
Time frame: day 5 post access creation
Diameter of the Brachial artery in mm
brachial artery diameter
Time frame: day 6 post access creation
Diameter of the Brachial artery in mm
brachial artery diameter
Time frame: day 7 post access creation
Diameter of the Brachial artery in mm
brachial artery diameter
Time frame: day 14 post access creation
Diameter of the Brachial artery in mm
brachial artery diameter
Time frame: day 21 post access creation
Diameter of the Brachial artery in mm
brachial artery diameter
Time frame: day 28 post access creation
Diameter of the Brachial artery in mm
brachial artery diameter
Time frame: day 60 post access creation
Diameter of the Brachial artery in mm
brachial artery diameter
Time frame: day 90 post access creation
Diameter of the Brachial artery in mm
Resistive index RI
Time frame: day 1 post access creation
Calculation of the Resistive Index of the Brachial artery
Resistive index RI
Time frame: day 2 post access creation
Calculation of the Resistive Index of the Brachial artery
Resistive index RI
Time frame: day 3 post access creation
Calculation of the Resistive Index of the Brachial artery
Resistive index RI
Time frame: day 4 post access creation
Calculation of the Resistive Index of the Brachial artery
Resistive index RI
Time frame: day 5 post access creation
Calculation of the Resistive Index of the Brachial artery
Resistive index RI
Time frame: day 6 post access creation
Calculation of the Resistive Index of the Brachial artery
Resistive index RI
Time frame: day 7 post access creation
Calculation of the Resistive Index of the Brachial artery
Resistive index RI
Time frame: day 14 post access creation
Calculation of the Resistive Index of the Brachial artery
Resistive index RI
Time frame: day 21 post access creation
Calculation of the Resistive Index of the Brachial artery
Resistive index RI
Time frame: day 28 post access creation
Calculation of the Resistive Index of the Brachial artery
Resistive index RI
Time frame: day 60 post access creation
Calculation of the Resistive Index of the Brachial artery
Resistive index RI
Time frame: day 90 post access creation
Calculation of the Resistive Index of the Brachial artery
Diameter of the efferent vein
Time frame: day 1 post access creation
Diameter of the the efferent vein in mm
Diameter of the efferent vein
Time frame: day 2 post access creation
Diameter of the the efferent vein in mm
Diameter of the efferent vein
Time frame: day 3 post access creation
Diameter of the the efferent vein in mm
Diameter of the efferent vein
Time frame: day 4 post access creation
Diameter of the the efferent vein in mm
Diameter of the efferent vein
Time frame: day 5 post access creation
Diameter of the the efferent vein in mm
Diameter of the efferent vein
Time frame: day 6 post access creation
Diameter of the the efferent vein in mm
Diameter of the efferent vein
Time frame: day 7 post access creation
Diameter of the the efferent vein in mm
Diameter of the efferent vein
Time frame: day 14 post access creation
Diameter of the the efferent vein in mm
Diameter of the efferent vein
Time frame: day 21 post access creation
Diameter of the the efferent vein in mm
Diameter of the efferent vein
Time frame: day 28 post access creation
Diameter of the the efferent vein in mm
Diameter of the efferent vein
Time frame: day 60 post access creation
Diameter of the the efferent vein in mm
Diameter of the efferent vein
Time frame: day 90 post access creation
Diameter of the the efferent vein in mm
Wall thickness of the efferent vein
Time frame: day 1 post access creation
Wall thickness of the efferent vein in mm
Wall thickness of the efferent vein
Time frame: day 2 post access creation
Wall thickness of the efferent vein in mm
Wall thickness of the efferent vein
Time frame: day 3 post access creation
Wall thickness of the efferent vein in mm
Wall thickness of the efferent vein
Time frame: day 4 post access creation
Wall thickness of the efferent vein in mm
Wall thickness of the efferent vein
Time frame: day 5 post access creation
Wall thickness of the efferent vein in mm
Wall thickness of the efferent vein
Time frame: day 6 post access creation
Wall thickness of the efferent vein in mm
Wall thickness of the efferent vein
Time frame: day 7 post access creation
Wall thickness of the efferent vein in mm
Wall thickness of the efferent vein
Time frame: day 14 post access creation
Wall thickness of the efferent vein in mm
Wall thickness of the efferent vein
Time frame: day 21 post access creation
Wall thickness of the efferent vein in mm
Wall thickness of the efferent vein
Time frame: day 28 post access creation
Wall thickness of the efferent vein in mm
Wall thickness of the efferent vein
Time frame: day 60 post access creation
Wall thickness of the efferent vein in mm
Wall thickness of the efferent vein
Time frame: day 90 post access creation
Wall thickness of the efferent vein in mm
4 secondary outcomes
Time of first successful cannulation
Time frame: 30 and 60 days
Successful hemodialysis
Time frame: 30 and 60 days
Primary patency
Time frame: 6 months
Surgeon-Nephrologist access site selection concordance
Time frame: At access creation (day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ioannis E Giannikouris, MD, MSc, PhD principal investigator
Mediterranean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End-stage Renal Disease and Hemodialysis Access Failure, run by Medifil AE at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume flow (time frame: day 1 post access creation). The study lists 60 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022; AzTrials last refreshed its copy on 30 Oct 2026.