Impact of Bevel Orientation on Arteriovenous Fistula Puncture in Hemodialysis
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Needle bevel orientation for arteriovenous fistula puncture
Procedure/SurgeryFor 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
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: Bevel-up groupActive comparator 1 intervention
Group B: Bevel-down groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluate the impact of needle bevel orientation (up versus down) on the occurrence of AVF complications during dialysis sessions over 12 months in patients with ESRD
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
During dialysis sessions over 12 months, from inclusionSecondary outcomes
1
Evaluate, in patients with CKD treated with hemodialysis, the impact of bevel orientation (up versus down) on the occurrence of AVF dysfunction requiring ultrasound during the first 24 months.
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 inclusion2
Evaluate, in patients with CKD treated with hemodialysis, the impact of bevel orientation (up versus down) on the occurrence of an intervention (surgical or radiointerventional) during the first 24 months
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 inclusion3
Evaluate, in patients with CKD treated with hemodialysis, the impact of bevel orientation (up versus down) on AVF survival.
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 24 months from inclusion4
Evaluate, in patients with CKD treated with hemodialysis, the impact of bevel orientation (up versus down) on patient discomfort with fistula pain during and between dialysis sessions over 12 months
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
For 12 months from inclusionSponsors and contacts
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Source ClinicalTrials.gov