FAV: Identifying Risk Factors for Early Arteriovenous Fistula Failure in Haemodialysis Patients

Sponsor
Centre Hospitalier Régional Metz-Thionville (Other)
Overall Status
Completed
CT.gov ID
NCT05552482
Collaborator
(none)
90
1
9
10

Study Details

Study Description

Brief Summary

The aim of this work is to identify the pre/perioperative factors that predict early AVF failure and to determine minimum vessel diameters that promote AVF function. We also sought to determine whether pre/perioperative factors could predict the key early postoperative vessel factors, namely, AVF blood flow, AVF vein diameter, change in internal AVF vein diameter, skin-AVF distance, and stenosis/thrombosis.

Condition or Disease Intervention/Treatment Phase
  • Other: Identification of predictive factors

Study Design

Study Type:
Observational
Actual Enrollment :
90 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Identification of Factors That Predict Early Arteriovenous Fistula Failure in Hemodialysis Patients
Actual Study Start Date :
Jan 5, 2021
Actual Primary Completion Date :
Oct 5, 2021
Actual Study Completion Date :
Oct 5, 2021

Arms and Interventions

Arm Intervention/Treatment
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
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

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
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

Outcome Measures

Primary Outcome Measures

  1. Identification of the pre/perioperative factors that predict early AVF failure [up to 3 months after AVF creation]

    Comparison of preoperative and intraoperative results according to composite factors of arteriovenous fistula failure: blood flow ≤ 500 ml/min, postoperative venous internal diameter VID ≤ 5 mm; complications: presence of stenosis, presence of thrombosis; AVF vein depth (external diameter) ≥ 6. The following variables were compared between groups: 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)

Secondary Outcome Measures

  1. Identification of the pre/perioperative factors that predict the early postoperative AVF blood flow [up to 3 months after AVF creation]

    Comparison of preoperative and intraoperative results according to AVF blood flow (AVF ≤ 500 ml/min vs AVF > 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)

  2. Identification of the pre/perioperative factors that predict the early postoperative venous internal diameter (VID) [up to 3 months after AVF creation]

    Comparison of preoperative and intraoperative results according to venous internal diameter (VID ≤ 5 mm vs > 5 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)

  3. Identification of the pre/perioperative factors that predict the early postoperative stenosis and/or thrombosis [up to 3 months after AVF creation]

    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)

  4. Identification of the pre/perioperative factors that predict the early postoperative venous external diameter [up to 3 months after AVF creation]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adult patients (≥ 18 years)

  • Patients who had undergone distal (radioradial and radiocephalic) or proximal arteriovenous fistula (AVF) access creation surgery between 2014 and 2021 at the CHR Metz-Thionville.

Exclusion Criteria:
  • Patients under 18 years of age,

  • Patients without preoperative venous mapping

  • Patients using the fistula for intermittent plasmapheresis

  • Patients with a radiobasilic AVF

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHR Metz-Thionville/Hopital de Mercy Metz France 57085

Sponsors and Collaborators

  • Centre Hospitalier Régional Metz-Thionville

Investigators

  • Principal Investigator: Zead TUBAIL, MD, CHR Metz Thionville Hopital de Mercy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Régional Metz-Thionville
ClinicalTrials.gov Identifier:
NCT05552482
Other Study ID Numbers:
  • 2022-06Obs-CHRMT
First Posted:
Sep 23, 2022
Last Update Posted:
Sep 26, 2022
Last Verified:
Sep 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 26, 2022