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Impact of Bevel Orientation on Arteriovenous Fistula Puncture in Hemodialysis

RecruitingNAAges 18 Years - 85 YearsAllCentre Hospitalier Emile Roux
NCT06708338 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 * Expected duration of dialysis ≥ 1 year * Double-needle dialysis * Hemodialysis possible on AVF * Average AVF flow rate between 500 and 2,000 mL/min * Affiliated with a social security scheme * Free and informed consent Exclusion Criteria: * Auto-dialysis at home * Puncture using the buttonhole technique * Patient requiring AVF puncture with a catheter * Planned transplant within the next 12 months * Previous AVF creation, except for the fistula of interest * Patient with a history of cancer within the past 5 years or active cancer * Patient under court protection or guardianship * Pregnant and breast-feeding women * Patient with psychiatric pathologies or cognitive disorders * Patient follow-up difficult or impossible for geographical or other reasons, at the investigator's discretion
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What it tests

  • Needle bevel orientation for arteriovenous fistula puncture
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Where

4 sites
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
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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