Impact of Bevel Orientation on Arteriovenous Fistula Puncture in Hemodialysis (FAVORI)

Impact of Bevel Orientation on Arteriovenous Fistula Puncture in Hemodialysis: A Multicenter Randomized Comparative Study

End-stage renal disease (ESRD) is a condition in which the filtration function of the kidneys has deteriorated, necessitating dialysis or transplantation. With an aging population, the number of patients undergoing dialysis for CKD is constantly increasing.

There are different types of dialysis treatment: hemodialysis and peritoneal dialysis.

Hemodialysis involves exchanges between blood and a dialysate (a liquid used to purify blood) via a dialyzer (artificial filter), coordinated by a generator. This method requires a vascular approach, of which there are 3 types: the arteriovenous fistula (AVF), the arteriovenous graft and the central venous catheter.

The AVF remains the vascular access of choice for hemodialysis sessions, and its preservation is an essential objective for patients with CKD.

One of the major challenges for AVFs is to achieve a successful puncture, an act performed around 310 times a year per patient, for dialysis performed three times a week with double needles. This repeated procedure can cause damage to the AVF, leading to complications such as stenosis, thrombosis, aneurysm, superficial infection, hematoma, bleeding, parietal rupture or dissection.

However, there is no official recommendation on the most conservative puncture technique for AVF. In view of the number of patients concerned and the recurrence of puncture, it would seem essential to evaluate the impact of bevel orientation on the occurrence of complications during dialysis by means of a randomized prospective study.

Study Overview

• Status: Not yet recruiting
• Conditions: End-Stage Renal Disease Requiring Haemodialysis
• Intervention / Treatment: Procedure: Needle bevel orientation for arteriovenous fistula puncture

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David SOULIER; Phone Number: 0471043875; Email: david.soulier@ch-lepuy.fr
• Study Contact Backup: Name: Camille FARCY; Email: favori@ch-lepuy.fr

Study Locations

• France
  • Le Puy-en-Velay, France, 43000
    • Centre Hospitalier Emile Roux
    • Contact: Claire REYMOND; Phone Number: 0471043403; Email: claire.reymond@ch-lepuy.fr
    • Contact: Julie GROS; Email: julie.gros@ch-lepuy.fr
    • Principal Investigator: Claire REYMOND
  • Lyon, France, 69007
    • Hopital Saint Joseph Saint Luc
    • Contact: Sophie MILLET; Phone Number: +33 4 78 61 87 14; Email: smillet@chsjsl.fr
    • Principal Investigator: Sophie MILLET
  • Moulins, France, 03000
    • Centre Hospitalier de Moulins-Yzeure
    • Contact: Nelly DOMPNIER; Phone Number: +33 4 70 35 79 69; Email: n.dompnier@ch-moulins-yzeure.fr
    • Principal Investigator: Nelly DOMPNIER
  • Poissy, France, 78303
    • Ctre Hospitalier Intercommunal Poissy St Germain Site Poissy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• male or female with Chronic Kidney Disease
• patient requiring 4-hour hemodialysis sessions, 3 times per week, in a dialysis center
• Native arteriovenous fistula (AVF) (without prosthesis), mature, with no prior puncture, located in the upper limb
• First fistula for a hemodialysis patient
• Expected duration of dialysis ≥ 1 year
• Double-needle dialysis
• Hemodialysis possible on AVF
• Average AVF flow rate between 500 and 2,000 mL/min
• Affiliated with a social security scheme
• Free and informed consent

Exclusion Criteria:

• Auto-dialysis at home
• Puncture using the buttonhole technique
• Patient requiring AVF puncture with a catheter
• Planned transplant within the next 12 months
• Previous AVF creation, except for the fistula of interest
• Patient with a history of cancer within the past 5 years or active cancer
• Patient under court protection or guardianship
• Pregnant and breast-feeding women
• Patient with psychiatric pathologies or cognitive disorders
• Patient follow-up difficult or impossible for geographical or other reasons, at the investigator's discretion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bevel-up group; AVF puncture will be performed with the needle bevel facing up for the entire duration of the patient's participation.	Procedure: Needle bevel orientation for arteriovenous fistula puncture; For the duration of the study (24 months from inclusion), the nurse will puncture the AVF according to the patient's randomization arm. Patients will be randomized, according to the minimization technique, in a 1:1 ratio between the following two groups: Bevel-up group; Bevel-down group
Experimental: Bevel-down group; AVF puncture will be performed with the needle bevel facing down for the entire duration of the patient's participation	Procedure: Needle bevel orientation for arteriovenous fistula puncture; For the duration of the study (24 months from inclusion), the nurse will puncture the AVF according to the patient's randomization arm. Patients will be randomized, according to the minimization technique, in a 1:1 ratio between the following two groups: Bevel-up group; Bevel-down group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the impact of needle bevel orientation (up versus down) on the occurrence of AVF complications during dialysis sessions over 12 months in patients with ESRD	The primary endpoint is the number of AVF complications over 12 months. Eight AVF complications will be collected (stenosis, thrombosis, aneurysm or aneurysm rupture, pseudoaneurysm, infection, hematoma, bleeding, rupture and/or parietal dissection).	During dialysis sessions over 12 months, from inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate, in patients with CKD treated with hemodialysis, the impact of bevel orientation (up versus down) on the occurrence of AVF dysfunction requiring ultrasound during the first 24 months.	Time from insured bipuncture to onset of AVF dysfunction (see complications in primary endpoint) requiring ultrasound over 24 months will be calculated.	For 24 months from inclusion
Evaluate, in patients with CKD treated with hemodialysis, the impact of bevel orientation (up versus down) on the occurrence of an intervention (surgical or radiointerventional) during the first 24 months	Time from insured bipuncture to onset of AVF dysfunction (see complications in primary endpoint) requiring initial intervention (surgical or radio-interventional) over 24 months will be calculated.	For 24 months from inclusion
Evaluate, in patients with CKD treated with hemodialysis, the impact of bevel orientation (up versus down) on AVF survival.	The time between the insured bipuncture and the discontinuation of its use over 24 months by the introduction of hemodialysis sessions via a central venous catheter or another AVF will be calculated	For 24 months from inclusion
Evaluate, in patients with CKD treated with hemodialysis, the impact of bevel orientation (up versus down) on AVF wall thickening at the puncture site at 6, 12 and 24 months.	Thickening of the AVF wall at the puncture site will be measured in mm by echo-Doppler at 6, 12 and 24 months.	At 6, 12 and 24 months from inclusion
Evaluate, in patients with CKD treated with hemodialysis, the impact of bevel orientation (up versus down) on patient discomfort with fistula pain during and between dialysis sessions over 12 months	Patient discomfort score for AVF pain during and between dialysis sessions, assessed using a simple verbal scale with a score ranging from 0 (pain free) to 4 (unbearable pain), at each session over 12 months	For 12 months from inclusion
Evaluate caregivers' feedback on the two puncture techniques and any changes in their practice in terms of AVF monitoring.	Feedback from caregivers will be evaluated via a qualitative questionnaire completed every 12 months starting from the fourth patient inclusion in each center. This aims to assess their experience with the two puncture techniques and any impact on their clinical practice.	At Month 12 (if at least 4 patients have been included in the center)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Emile Roux

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: November 25, 2024
• First Posted (Actual): November 27, 2024

Study Record Updates

• Last Update Posted (Actual): July 31, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: arteriovenous fistula; puncture technique; vascular approach
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Male Urogenital Diseases; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Congenital Abnormalities; Cardiovascular Abnormalities; Renal Insufficiency, Chronic; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Kidney Failure, Chronic; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: RIPH2_SOULIER_FAVORI; 2024-A01536-41 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No