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

Completed

• Conditions: Arteriovenous Fistula; End Stage Chronic Renal Failure; Hemodialysis
• Interventions: Other: Identification of predictive factors

• Registration Number: NCT05552482
• Lead Sponsor: Centre Hospitalier Régional Metz-Thionville

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-05
• Primary Completion: 2021-10-05
• Study First Submitted: 2022-09-21
• Study First Submitted QC: 2022-09-21
• Study First Posted: 2022-09-23
• Study Completion: 2022-12-21
• Status Verified: 2023-02
• Last Update Submitted: 2023-03-08
• Last Update Posted: 2023-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with ESRD with early AVF failure	Identification of predictive factors	Patients with ESRD who underwent AVF access creation surgery with early AVF failure
patients with ESRD without early AVF failure	Identification of predictive factors	Patients with ESRD who underwent AVF access creation surgery without early AVF failure

Primary Outcome Measures

Name	Time	Method
Identification of the pre/perioperative factors that predict early AVF failure (eAVFF)	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 Outcome Measures

Name	Time	Method
Identification of the pre/perioperative factors that predict the early postoperative AVF blood flow (PostQa)	up to 3 months after AVF creation	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)
Identification of the pre/perioperative factors that predict the early postoperative venous internal diameter (PostVD)	up to 3 months after AVF creation	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)
Identification of the pre/perioperative factors that predict the early postoperative AVF 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)
Identification of the pre/perioperative factors that predict the early postoperative skin to AVF distance	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)

Trial Locations

Locations (1)

CHR Metz-Thionville/Hopital de Mercy; 🇫🇷 Metz, France