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Clinical Trials/NCT05552482
NCT05552482
Completed
Not Applicable

Identification of Factors That Predict Early Haemodialysis Arteriovenous Fistula Failure

Centre Hospitalier Régional Metz-Thionville1 site in 1 country105 target enrollmentJanuary 5, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arteriovenous Fistula
Sponsor
Centre Hospitalier Régional Metz-Thionville
Enrollment
105
Locations
1
Primary Endpoint
Identification of the pre/perioperative factors that predict early AVF failure (eAVFF)
Status
Completed
Last Updated
3 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
January 5, 2021
End Date
December 21, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre Hospitalier Régional Metz-Thionville
Responsible Party
Sponsor

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • Identification of the pre/perioperative factors that predict the early postoperative AVF blood flow (PostQa)(up to 3 months after AVF creation)
  • Identification of the pre/perioperative factors that predict the early postoperative venous internal diameter (PostVD)(up to 3 months after AVF creation)
  • Identification of the pre/perioperative factors that predict the early postoperative AVF stenosis and/or thrombosis(up to 3 months after AVF creation)
  • Identification of the pre/perioperative factors that predict the early postoperative skin to AVF distance(up to 3 months after AVF creation)

Study Sites (1)

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