Impact of Bevel Orientation on Arteriovenous Fistula Puncture in Hemodialysis

NCT ID: NCT06708338

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2029-06-30

Brief Summary

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.

Conditions

End-Stage Renal Disease Requiring Haemodialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Bevel-up group

AVF puncture will be performed with the needle bevel facing up for the entire duration of the patient's participation.

Group Type: ACTIVE_COMPARATOR

Needle bevel orientation for arteriovenous fistula puncture

Intervention Type: PROCEDURE

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

Bevel-down group

AVF puncture will be performed with the needle bevel facing down for the entire duration of the patient's participation

Group Type: EXPERIMENTAL

Needle bevel orientation for arteriovenous fistula puncture

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Emile Roux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Emile Roux

Le Puy-en-Velay, , France

Hôpital Saint Joseph Saint Luc

Lyon, , France

Centre Hospitalier de Moulins-Yzeure

Moulins, , France

Ctre Hospitalier Intercommunal Poissy St Germain Site Poissy

Poissy, , France

Countries

France

Central Contacts

David SOULIER

Role: CONTACT

david.soulier@ch-lepuy.fr

0471043875

Camille FARCY

Role: CONTACT

favori@ch-lepuy.fr

Facility Contacts

Claire REYMOND

Role: primary

claire.reymond@ch-lepuy.fr

0471043403

Julie GROS

Role: backup

julie.gros@ch-lepuy.fr

Sophie MILLET

Role: primary

smillet@chsjsl.fr

+33 4 78 61 87 14

Nelly DOMPNIER

Role: primary

n.dompnier@ch-moulins-yzeure.fr

+33 4 70 35 79 69

Other Identifiers

2024-A01536-41

Identifier Type: OTHER

Identifier Source: secondary_id

RIPH2_SOULIER_FAVORI

Identifier Type: -

Identifier Source: org_study_id