Impact of Bevel Orientation on Arteriovenous Fistula Puncture in Hemodialysis

NCT06708338 | Not Yet Recruiting

• 2 other identifiers: RIPH2_SOULIER_FAVORI2024-A01536-41
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 4

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

Keywords

arteriovenous fistula; puncture technique; vascular approach

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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.

  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

  For 24 months from inclusion

• Evaluate, in patients with CKD treated with hemodialysis, the impact of bevel orientation (up versus down) on AVF survival.

  For 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

  For 12 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.

  At 6, 12 and 24 months from inclusion

Study Arms (2)

Bevel-up group

ACTIVE COMPARATOR

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

Bevel-down group

EXPERIMENTAL

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

Interventions

Needle bevel orientation for arteriovenous fistula puncture 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; Bevel-up group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Emile Roux: lead

Study Sites (4)

Centre Hospitalier Emile Roux

Le Puy-en-Velay, 43000, France

Location

Hôpital Saint Joseph Saint Luc

Lyon, 69007, France

Location

Centre Hospitalier de Moulins-Yzeure

Moulins, 03000, France

Location

Ctre Hospitalier Intercommunal Poissy St Germain Site Poissy

Poissy, 78303, France

Location

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

David SOULIER

CONTACT

0471043875; david.soulier@ch-lepuy.fr

Camille FARCY

CONTACT

favori@ch-lepuy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 27, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

FR (4)