Arteriovenous FistulaeAVFF-RFNCT05552482
Identifying Risk Factors (RF) for Early Haemodialysis Arteriovenous Fistula Failure (eAVFF)
An observational study of Arteriovenous Fistula and Hemodialysis, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial summary
Arteriovenous fisutla (AVF) is the vascular access of choice for hemodialysis but has a high early failure (eAVFF) rate. eAVFF can be defined as thrombosis/stenosis and Doppler ultrasound (DUS)-based failure-to-mature parameters such as postoperative blood flow (PostQa) < 500 ml/min, AVF-vein diameter (PostVD) < 5 mm… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriovenous Fistula, Hemodialysis, End Stage Chronic Renal Failure
- What is being tested?
- Identification of predictive factors
- How many people
- 105 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jan 2021to 21 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (≥ 18 years) who had undergone distal (radioradial and radiocephalic) and proximal arteriovenous fistula (AVF) access creation surgery
Who may be able to join
- Adult patients (≥ 18 years)
- Patients who had undergone distal (radioradial and radiocephalic) or proximal arteriovenous fistula (AVF) access creation surgery between 2016 and 2021 at the CHR Metz-Thionville.
- Patients who underwent preoperative and postoperative Doppler ultrasound (DUS) ≤ 4 months after surgery.
- Patients with central venous catheter (CVC) at surgery
Who cannot join
- Patients using the fistula for intermittent plasmapheresis
- Patients with a radiobasilic AVF or arteriovenous graft
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of Factors That Predict Early Haemodialysis Arteriovenous Fistula Failure
Arteriovenous fisutla (AVF) is the vascular access of choice for hemodialysis but has a high early failure (eAVFF) rate. eAVFF can be defined as thrombosis/stenosis and Doppler ultrasound (DUS)-based failure-to-mature parameters such as postoperative blood flow (PostQa) < 500 ml/min, AVF-vein diameter (PostVD) < 5 mm, and AVF-vein depth (PostVDepth) ≥ 6 mm. We explored whether common risk factors for eAVFF could predict these eAVFF parameters and venous distensibility: the latter is largely overlooked as a potential eAVFF parameter.
- Being tested
- Identification of predictive factors
- Medical subject headings
- Arteriovenous Fistula, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Identification of predictive factorsOther
Evaluation of the following variables : age, sex, body mass index, Diabetes mellitus, vascular disease, hematologic disease, venous thromboembolic disease, antiplatelet or anticoagulant treatments, haemodialysis Catheter Insertion, number of comorbid conditions, Venous diameter, Arterial diameter, AVF type, AVF limb, Anasthesia group
| Study group | Role | What they receive |
|---|---|---|
| Patients with ESRD with early AVF failure | Patients with ESRD who underwent AVF access creation surgery with early AVF failure Receives: Other: Identification of predictive factors | |
| patients with ESRD without early AVF failure | Patients with ESRD who underwent AVF access creation surgery without early AVF failure Receives: Other: Identification of predictive factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of the pre/perioperative factors that predict early AVF failure (eAVFF)
Comparison of preoperative and intraoperative results according to composite factors of arteriovenous fistula failure: Qa blood flow < 500 ml/min, postoperative venous internal diameter PostVD < 5 mm; complications: presence of stenosis, presence of thrombosis; AVF vein depth (external diameter) (PostVDepth) ≥ 6.
The following variables were compared between groups: age (years) , sex (Man/Women), body mass index (kg/m2), Comorbidities [Diabetes mellitus (yes/no), obesity (yes/no)], Preoperative hemoglobin (g/dl); locoregional anesthesia (yes/no), Central Venous Catether (CVC) use (yes/no); CVC use on same side as AVF (yes/no); AVF on left side of body (yes/no); Distal AVF location (yes/no); Preop AVF vessel diameter (artery and vein; mm).
Measured: up to 3 months after AVF creation
Secondary outcomes (4)
Identification of the pre/perioperative factors that predict the early postoperative AVF blood flow (PostQa)
Comparison of preoperative and intraoperative results according to AVF blood flow (Qa < 500 ml/min) for the following variables: age (years) , sex (Man/Women), body mass index (kg/m2), Diabetes mellitus (yes/no), vascular disease (yes/no), hematologic disease (yes/no), venous thromboembolic disease (yes/no), antiplatelet or anticoagulant treatments (yes/no), haemodialysis Catheter Insertion (yes/no), the number of comorbid conditions (1, 2, 3 and 4), Venous diameter (mm), Arterial diameter (mm), AVF type (Brachiocephalic/Radiocephalic), AVF limb (left/right), Anasthesia group (local/general)
Measured: up to 3 months after AVF creation
Identification of the pre/perioperative factors that predict the early postoperative venous internal diameter (PostVD)
Comparison of preoperative and intraoperative results according to venous internal diameter (PostVD < 5 mm vs > 5 mm) for the following variables: age (years) , sex (Man/Women), body mass index (BMI: kg/m2), Comorbidities (Diabetes mellitus (yes/no), vascular disease (yes/no), hematologic disease (yes/no), venous thromboembolic disease (yes/no), antiplatelet or anticoagulant treatments (yes/no), haemodialysis Catheter Insertion (yes/no), the number of comorbid conditions (1, 2, 3 and 4), Venous diameter (mm), Arterial diameter (mm), AVF type (Brachiocephalic/Radiocephalic), AVF limb (left/right), Anasthesia group (local/general)
Measured: up to 3 months after AVF creation
Identification of the pre/perioperative factors that predict the early postoperative AVF stenosis and/or thrombosis
Comparison of preoperative and intraoperative results according to stenosis and/or thrombosis (stenosis or thrombosis vs no complications) for the following variables: age (years) , sex (Man/Women), body mass index (kg/m2), Diabetes mellitus (yes/no), vascular disease (yes/no), hematologic disease (yes/no), venous thromboembolic disease (yes/no), antiplatelet or anticoagulant treatments (yes/no), haemodialysis Catheter Insertion (yes/no), the number of comorbid conditions (1, 2, 3 and 4), Venous diameter (mm), Arterial diameter (mm), AVF type (Brachiocephalic/Radiocephalic), AVF limb (left/right), Anasthesia group (local/general)
Measured: up to 3 months after AVF creation
Identification of the pre/perioperative factors that predict the early postoperative skin to AVF distance
Comparison of preoperative and intraoperative results according to skin-AVF distance (< 6 mm vs ≥ 6 mm) for the following variables: age (years) , sex (Man/Women), body mass index (kg/m2), Diabetes mellitus (yes/no), vascular disease (yes/no), hematologic disease (yes/no), venous thromboembolic disease (yes/no), antiplatelet or anticoagulant treatments (yes/no), haemodialysis Catheter Insertion (yes/no), the number of comorbid conditions (1, 2, 3 and 4), Venous diameter (mm), Arterial diameter (mm), AVF type (Brachiocephalic/Radiocephalic), AVF limb (left/right), Anasthesia group (local/general)
Measured: up to 3 months after AVF creation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start5 Jan 2021
- Primary completion5 Oct 2021
- Study completion21 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous FistulaStudies 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
- Retrospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zead TUBAIL, MD, Principal investigator, CHR Metz Thionville Hopital de Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552482
- Sponsor's protocol ID
- 2022-06Obs-CHRMT
- Acronym
- eAVFF-RF
- Status last verified
- Feb 2023
- First submitted
- 21 Sep 2022
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Factors That Predict Early Haemodialysis Arteriovenous Fistula Failure
- ClinicalTrials.gov ID
- NCT05552482
- Acronym / sponsor ID
- eAVFF-RF / 2022-06Obs-CHRMT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 5 Oct 2021 (actual)
- Study completion
- 21 Dec 2022 (actual)
- First posted
- 23 Sep 2022 (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.
Arteriovenous fisutla (AVF) is the vascular access of choice for hemodialysis but has a high early failure (eAVFF) rate. eAVFF can be defined as thrombosis/stenosis and Doppler ultrasound (DUS)-based failure-to-mature parameters such as postoperative blood flow (PostQa) < 500 ml/min, AVF-vein diameter (PostVD) < 5 mm, and AVF-vein depth (PostVDepth) ≥ 6 mm. We explored whether common risk factors for eAVFF could predict these eAVFF parameters and venous distensibility: the latter is largely overlooked as a potential eAVFF parameter.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with ESRD with early AVF failure | – | Other: Identification of predictive factorsPatients with ESRD who underwent AVF access creation surgery with early AVF failure |
| patients with ESRD without early AVF failure | – | Other: Identification of predictive factorsPatients with ESRD who underwent AVF access creation surgery without early AVF failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥ 18 years) who had undergone distal (radioradial and radiocephalic) and proximal arteriovenous fistula (AVF) access creation surgery
Key inclusion criteria (4 listed)
- Adult patients (≥ 18 years)
- Patients who had undergone distal (radioradial and radiocephalic) or proximal arteriovenous fistula (AVF) access creation surgery between 2016 and 2021 at the CHR Metz-Thionville.
- Patients who underwent preoperative and postoperative Doppler ultrasound (DUS) ≤ 4 months after surgery.
- Patients with central venous catheter (CVC) at surgery
Key exclusion criteria (2 listed)
- Patients using the fistula for intermittent plasmapheresis
- Patients with a radiobasilic AVF or arteriovenous graft
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 |
|---|---|---|
| Identification of predictive factorsEvaluation of the following variables : age, sex, body mass index, Diabetes mellitus, vascular disease, hematologic disease, venous thromboembolic disease, antiplatelet or anticoagulant treatments, haemodialysis Catheter Insertion, number of comorbid conditions, Venous diameter, Arterial diameter, AVF type, AVF limb, Anasthesia group | Other | Patients with ESRD with early AVF failure, patients with ESRD without early AVF failure |
Primary outcome
Identification of the pre/perioperative factors that predict early AVF failure (eAVFF)
Time frame: up to 3 months after AVF creation
Comparison of preoperative and intraoperative results according to composite factors of arteriovenous fistula failure: Qa blood flow < 500 ml/min, postoperative venous internal diameter PostVD < 5 mm; complications: presence of stenosis, presence of thrombosis; AVF vein depth (external diameter) (PostVDepth) ≥ 6. The following variables were compared between groups: age (years) , sex (Man/Women), body mass index (kg/m2), Comorbidities [Diabetes mellitus (yes/no), obesity (yes/no)], Preoperative hemoglobin (g/dl); locoregional anesthesia (yes/no), Central Venous Catether (CVC) use (yes/no); CVC use on same side as AVF (yes/no); AVF on left side of body (yes/no); Distal AVF location (yes/no); Preop AVF vessel diameter (artery and vein; mm).
4 secondary outcomes
Identification of the pre/perioperative factors that predict the early postoperative AVF blood flow (PostQa)
Time frame: up to 3 months after AVF creation
Identification of the pre/perioperative factors that predict the early postoperative venous internal diameter (PostVD)
Time frame: up to 3 months after AVF creation
Identification of the pre/perioperative factors that predict the early postoperative AVF stenosis and/or thrombosis
Time frame: up to 3 months after AVF creation
Identification of the pre/perioperative factors that predict the early postoperative skin to AVF distance
Time frame: up to 3 months after AVF creation
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 10 Mar 2023.
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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.
Zead TUBAIL, MD principal investigator
CHR Metz Thionville Hopital de Mercy
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 Arteriovenous Fistula and Hemodialysis, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
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 4 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 10 Mar 2023. 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 France. 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?
Identification of the pre/perioperative factors that predict early AVF failure (eAVFF) (time frame: up to 3 months after AVF creation). 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 10 Mar 2023; AzTrials last refreshed its copy on 8 Nov 2026.