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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A01536-41 | Other Identifier | ID-RCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevel-up group | Active Comparator | AVF puncture will be performed with the needle bevel facing up for the entire duration of the patient's participation. |
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| Bevel-down group | Experimental | AVF puncture will be performed with the needle bevel facing down for the entire duration of the patient's participation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Needle bevel orientation for arteriovenous fistula puncture | Procedure | 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:
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | During dialysis sessions over 12 months, from inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | For 24 months from inclusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David SOULIER | Contact | 0471043875 | david.soulier@ch-lepuy.fr | |
| Camille FARCY | Contact | favori@ch-lepuy.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Emile Roux | Le Puy-en-Velay | 43000 | France |
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| ID | Term |
|---|---|
| D001164 | Arteriovenous Fistula |
| ID | Term |
|---|---|
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
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| 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. | For 24 months from inclusion |
| 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 | For 24 months from inclusion |
| 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 | For 12 months from inclusion |
| Evaluate, in patients with CKD treated with hemodialysis, the impact of bevel orientation (up versus down) on AVF wall thickening at the puncture site at 6, 12 and 24 months. | Thickening of the AVF wall at the puncture site will be measured in mm by echo-Doppler at 6, 12 and 24 months. | At 6, 12 and 24 months from inclusion |
| Evaluate caregivers' feedback on the two puncture techniques and any changes in their practice in terms of AVF monitoring. | 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. | At Month 12 (if at least 4 patients have been included in the center) |
| Hôpital Saint Joseph Saint Luc | Lyon | 69007 | France |
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| Centre Hospitalier de Moulins-Yzeure | Moulins | 03000 | France |
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| Ctre Hospitalier Intercommunal Poissy St Germain Site Poissy | Poissy | 78303 | France |
| D016157 | Vascular Fistula |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |