Impact of Bevel Orientation on Arteriovenous Fistula Puncture in Hemodialysis

Not Applicable

Not yet recruiting

• Conditions: End-Stage Renal Disease Requiring Haemodialysis

• Registration Number: NCT06708338
• Lead Sponsor: Centre Hospitalier Emile Roux

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2024-11-25
• Study First Posted: 2024-11-27
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04
• Study Start: 2025-01-01
• Primary Completion: 2028-06-30
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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	During dialysis sessions over 12 months, from inclusion	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).

Secondary Outcome Measures

Name	Time	Method
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	Time from insured bipuncture to onset of AVF dysfunction (see complications in primary endpoint) requiring ultrasound over 24 months will be calculated.
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	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.
Evaluate, in patients with CKD treated with hemodialysis, the impact of bevel orientation (up versus down) on AVF survival.	For 24 months from inclusion	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
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	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
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	Thickening of the AVF wall at the puncture site will be measured in mm by echo-Doppler at 6, 12 and 24 months.
Evaluate caregivers' feedback on the two puncture techniques and any changes in their practice in terms of AVF monitoring.	At 12 months from inclusion	Feedback from caregivers will be evaluated at 12 months via a qualitative questionnaire (drawn up for the study by the project team).

Trial Locations

Locations (1)

Centre Hospitalier Emile Roux; 🇫🇷 Le Puy-en-Velay, France