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NOT YET RECRUITING
NCT06708338
NA

Impact of Bevel Orientation on Arteriovenous Fistula Puncture in Hemodialysis

Sponsor: Centre Hospitalier Emile Roux

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2025-12-01

Completion Date

2029-06-30

Last Updated

2025-07-31

Healthy Volunteers

No

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

Locations (4)

Centre Hospitalier Emile Roux

Le Puy-en-Velay, France

Hôpital Saint Joseph Saint Luc

Lyon, France

Centre Hospitalier de Moulins-Yzeure

Moulins, France

Ctre Hospitalier Intercommunal Poissy St Germain Site Poissy

Poissy, France