Impact of Bevel Orientation on Arteriovenous Fistula Puncture in Hemodialysis: A Multicenter Randomized Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 12
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Bevel-up group
AVF puncture will be performed with the needle bevel facing up for the entire duration of the patient's participation.
干预措施: Needle bevel orientation for arteriovenous fistula puncture (Procedure)
Bevel-down group
AVF puncture will be performed with the needle bevel facing down for the entire duration of the patient's participation
干预措施: Needle bevel orientation for arteriovenous fistula puncture (Procedure)
结局指标
主要结局
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
时间窗: 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).
次要结局
- 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.(For 24 months from inclusion)
- 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(For 24 months from inclusion)
- Evaluate, in patients with CKD treated with hemodialysis, the impact of bevel orientation (up versus down) on AVF survival.(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(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.(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.(At Month 12 (if at least 4 patients have been included in the center))
- 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.(For 24 months from inclusion)
- 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(For 24 months from inclusion)
- Evaluate, in patients with CKD treated with hemodialysis, the impact of bevel orientation (up versus down) on AVF survival.(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(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.(At 6, 12 and 24 months from inclusion)