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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Centre Hospitalier Emile Roux
RECRUITING
Le Puy-en-velay
Hôpital Saint Joseph Saint Luc
NOT_YET_RECRUITING
Lyon
Centre Hospitalier de Moulins-Yzeure
NOT_YET_RECRUITING
Moulins
Ctre Hospitalier Intercommunal Poissy St Germain Site Poissy
NOT_YET_RECRUITING
Poissy
Contact Information
Primary
David SOULIER
david.soulier@ch-lepuy.fr
0471043875
Backup
Camille FARCY
favori@ch-lepuy.fr
Time Frame
Start Date: 2026-01-07
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 240
Treatments
Active_comparator: Bevel-up group
AVF puncture will be performed with the needle bevel facing up for the entire duration of the patient's participation.
Experimental: Bevel-down group
AVF puncture will be performed with the needle bevel facing down for the entire duration of the patient's participation
Sponsors
Leads: Centre Hospitalier Emile Roux

This content was sourced from clinicaltrials.gov