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

Completed

• Conditions: Arteriovenous Fistula; End Stage Chronic Renal Failure; Hemodialysis

• 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

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