Impact of Bevel Orientation on Arteriovenous Fistula Puncture in Hemodialysis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorCentre Hospitalier Emile Roux

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Auto-dialysis at home

Puncture using the buttonhole technique

Patient requiring AVF puncture with a catheter

Planned transplant within the next 12 months

Trial design

Treatments tested in this trial

  • Needle bevel orientation for arteriovenous fistula puncture

Treatment groups

240 Participants
are divided into 2 treatment groups

Sponsors and collaborators