Impact of Bevel Orientation on Arteriovenous Fistula Puncture in Hemodialysis

Official title

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

Overview

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.

Interventions

• 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

Primary outcome measures

• 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 [Time frame: During dialysis sessions over 12 months, from inclusion]

Secondary outcome measures (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. [Time frame: 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 frame: For 24 months from inclusion]
• Evaluate, in patients with CKD treated with hemodialysis, the impact of bevel orientation (up versus down) on AVF survival. [Time frame: 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 [Time frame: 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. [Time frame: At 6, 12 and 24 months from inclusion]
• Evaluate caregivers' feedback on the two puncture techniques and any changes in their practice in terms of AVF monitoring. [Time frame: At Month 12 (if at least 4 patients have been included in the center)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

France · 4 centers

• Centre Hospitalier Emile Roux — Le Puy-en-Velay
• Hôpital Saint Joseph Saint Luc — Lyon
• Centre Hospitalier de Moulins-Yzeure — Moulins
• Ctre Hospitalier Intercommunal Poissy St Germain Site Poissy — Poissy

Identifiers

NCT: NCT06708338 · RIPH2_SOULIER_FAVORI · 2024-A01536-41

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗