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CompletedNCT05552482eAVFF-RFUpdated Mar 10, 2023

Identifying Risk Factors (RF) for Early Haemodialysis Arteriovenous Fistula Failure (eAVFF)

An observational study in Arteriovenous Fistula, Hemodialysis and End Stage Chronic Renal Failure, sponsored by Centre Hospitalier Régional Metz-Thionville. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-10.

Sponsored by Centre Hospitalier Régional Metz-Thionville · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
105
Ages
18 Years and older
Sex
All
01

Study 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, 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.

02

Conditions studied

  • Arteriovenous Fistula
  • Hemodialysis
  • End Stage Chronic Renal Failure
03

In context

Kidney Failure, Chronic

2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.

This study's enrollment of 105 is below the median of 120 across 431 observational studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

Centre Hospitalier Régional Metz-Thionville is the lead sponsor of 118 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients (≥ 18 years) who had undergone distal (radioradial and radiocephalic) and proximal arteriovenous fistula (AVF) access creation surgery

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Patients using the fistula for intermittent plasmapheresis
  • Patients with a radiobasilic AVF or arteriovenous graft
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
105 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with ESRD with early AVF failure

    Patients with ESRD who underwent AVF access creation surgery with early AVF failure

    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

    Other: Identification of predictive factors

Interventions

  • OtherIdentification of predictive factors

    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

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: up to 3 months after AVF creation

Secondary outcomes

  1. 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)

    Time frame: up to 3 months after AVF creation

  2. 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)

    Time frame: up to 3 months after AVF creation

  3. 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)

    Time frame: up to 3 months after AVF creation

  4. 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)

    Time frame: up to 3 months after AVF creation

07

Study locations

1 site
  • CHR Metz-Thionville/Hopital de Mercy
    Metz, 57085, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05552482
Lead sponsor
Centre Hospitalier Régional Metz-Thionville
Responsible party
Sponsor
First posted
Sep 23, 2022
Start date
Jan 5, 2021
Primary completion
Oct 5, 2021
Completion
Dec 21, 2022
Last update
Mar 10, 2023

Study contacts

Zead TUBAIL, MD
principal investigator · CHR Metz Thionville Hopital de Mercy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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