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

Identification of Factors That Predict Early Haemodialysis Arteriovenous Fistula Failure

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05552482
Acronym
eAVFF-RF
Enrollment
105
Registered
2022-09-23
Start date
2021-01-05
Completion date
2022-12-21
Last updated
2023-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arteriovenous Fistula, End Stage Chronic Renal Failure, Hemodialysis

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.

Interventions

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

Sponsors

Centre Hospitalier Régional Metz-Thionville
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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 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

Design outcomes

Primary

MeasureTime frameDescription
Identification of the pre/perioperative factors that predict early AVF failure (eAVFF)up to 3 months after AVF creationComparison 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

MeasureTime frameDescription
Identification of the pre/perioperative factors that predict the early postoperative AVF blood flow (PostQa)up to 3 months after AVF creationComparison 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)
Identification of the pre/perioperative factors that predict the early postoperative venous internal diameter (PostVD)up to 3 months after AVF creationComparison 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)
Identification of the pre/perioperative factors that predict the early postoperative AVF stenosis and/or thrombosisup to 3 months after AVF creationComparison 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)
Identification of the pre/perioperative factors that predict the early postoperative skin to AVF distanceup to 3 months after AVF creationComparison 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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026