NCT Number: NCT06708338
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.
Trial opening soon.
Get Notified18 year–85 year
All sexes
Interventional
Not applicable
Centre Hospitalier Emile Roux, Le Puy-en-Velay, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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:
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: At Month 12 (if at least 4 patients have been included in the center)
Feedback from caregivers will be evaluated via a qualitative questionnaire completed every 12 months starting from the fourth patient inclusion in each center. This aims to assess their experience with the two puncture techniques and any impact on their clinical practice.
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Emile Roux
Other
Impact of Bevel Orientation on Arteriovenous Fistula Puncture in Hemodialysis: A Multicenter Randomized Comparative Study
Acronym: FAVORI
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