Monitoring of Dialysis Vascular Accesses During Angioplasty Under Echodoppler (SAVE)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- morbidity and mortality
研究概览
简要总结
Dialysis vascular accesses called arteriovenous fistulas ( AVF) are essential to ensure extra-renal purification by hemodialysis for patients with chronic end-stage renal disease. Complications of dialysis AVF cause significant morbidity and hospitalization. Dialysis AVF angioplasties are frequently used to treat stenosis, the 1st complication concerning them and which announces the complete thrombosis which may be the definitive loss of the AVF. Historically performed under X-ray, the progression in the quality of ultrasound scanners allows today to perform this procedure under echo-Doppler guidance and thus to avoid both radiation and the injection of iodinated contrast products and their complications. It is thus possible to preserve residual renal function, a situation with a better prognosis, or to help the maturation of the AVF without precipitating the patient towards dialysis. The procedure can then be less costly, requiring a much lighter infrastructure.
The complication rates of ultrasound angioplasty remain poorly known because only a few series have been published. In addition, the evolution of the echo-Doppler parameters of the AVF is unknown during angioplasty and it is difficult to know which are the most reliable to distinguish during the procedure a "good angioplasty gesture" from an incomplete angioplasty to be continued. The proposed study would provide initial insight into the question posed.
详细描述
This is an observational, retrospective study on data from routine care. All angioplasties concerning major patients, meeting the inclusion criteria and performed during the inclusion period will be taken into account. (For this purpose, a list of procedures performed at the Vichy Hospital will be established via the angioplasty procedure reports.
In order to establish the evolution of the echographic parameters over time, the echographic data will also be collected from each follow-up report corresponding to each procedure until the end of the follow-up. These reports correspond to the normal post-intervention control ultrasounds at 1 month, 3 months and the annual visits. If intermediate ultrasounds are available, their reports will also be used.
In the case of a patient having an emergency angioplasty, the data of the control ultrasound triggering the intervention will be used as pre-intervention data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old
- •Patient undergoing whose fistula is treated by angioplasty under echo-doplerat the Vichy Hospital Center between 01/01/2015 and 31/12/2019
排除标准
- •Patients who are minors,
- •Patients with an AVF with a flow rate < 100 mL/min.
- •Patients with acute or chronic, segmental or total occlusion of an AVF segment
- •Patients with acute or chronic, segmental or total thrombosis of an AVF segment
- •Patients whose main obstacle is located on the arterial side.
- •Intervention that required the use of X-rays.
结局指标
主要结局
morbidity and mortality
时间窗: during intervention
The primary outcome measure to evaluate morbidity and mortality will be the number of acute complications that occurred during the procedure and by type of complication (wall hematoma, thrombosis, rupture, spasm, injection site hematoma, pseudoaneurysm, failure)
次要结局
- Post-angioplasty permeability(2 years)
- Endoluminal reference diameter(pre-intervention, immediately after the intervention, 1 month)
- Maximum systolic velocity (VSmax)(pre-intervention, immediately after the intervention, 1 month)
- Ratio of VSmax to upstream(pre-intervention, immediately after the intervention, 1 month)
- Diameter of the anastomosis(pre-intervention, immediately after the intervention, 1 month)
- Brachial artery Resistance Index(pre-intervention, immediately after the intervention, 1 month)
- End-diastolic velocity(pre-intervention, immediately after the intervention, 1 month)
- Brachial artery Maximum flow(pre-intervention, immediately after the intervention, 1 month)
- Brachial artery end-diastolic velocity (EDV)(pre-intervention, immediately after the intervention, 1 month)
- Stenosis diameter(pre-intervention, immediately after the intervention, 1 month)
- Brachial artery maximum systolic velocity(pre-intervention, immediately after the intervention, 1 month)