NCT06708338

Impact of Bevel Orientation on Arteriovenous Fistula Puncture in Hemodialysis

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Centre Hospitalier Emile Roux · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-12-01
• Primary completion: 2028-06-30
• Completion: 2029-06-30
• First posted: 2024-11-27
• Last updated: 2025-07-31

Locations

4 sites across 1 country: France