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

Identification of Factors That Predict Early Haemodialysis Arteriovenous Fistula Failure

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.

Study Overview

• Status: Completed
• Conditions: Hemodialysis; Arteriovenous Fistula; End Stage Chronic Renal Failure
• Intervention / Treatment: Other: Identification of predictive factors

• Study Type: Observational
• Enrollment (Actual): 105

Contacts and Locations

Study Locations

• France
  • Metz, France, 57085
    • CHR Metz-Thionville/Hopital de Mercy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥ 18 years) who had undergone distal (radioradial and radiocephalic) and proximal arteriovenous fistula (AVF) access creation surgery

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of the pre/perioperative factors that predict early AVF failure (eAVFF)	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).	up to 3 months after AVF creation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional Metz-Thionville
• Investigators: Principal Investigator: Zead TUBAIL, MD, CHR Metz Thionville Hopital de Mercy

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2021
• Primary Completion (Actual): October 5, 2021
• Study Completion (Actual): December 21, 2022

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Congenital Abnormalities; Renal Insufficiency; Pathological Conditions, Anatomical; Renal Insufficiency, Chronic; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Kidney Failure, Chronic; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: 2022-06Obs-CHRMT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No