OStéopontin as a Marker Of StenoSIS - OSMOSIS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Plasmatic osteopontin level
研究概览
简要总结
Our hypothesis is that a plasma protein named osteopontin (OPN) could serve as a biological predictive marker of acute AVF dysfunction. In several scientific studies, plasma OPN was correlated with coronary stent restenosis, and with cardiovascular outcome in patients with diabetes and renal insufficiency. This protein is secreted by several cellular types, like distal tubule epithelial cells, macrophages, but also fibroblasts and cardiac and vascular endothelial cells, in response to several specific stimuli. It acts like a cytokine, inducing immunological mechanisms as well as tissue remodeling.
The main objective of this study is to show that the amount of plasma OPN is higher in patients presenting with an AVF stenosis, compared with patients with a functioning AVF.
OSMOSIS is a monocentric pilot study that will include patients into two groups during 12 months (no specific follow-up). The control group will include patients that have been dialyzed on an AVF, in the dialysis center of Nice University Hospital, for at least 3 months without any incident. The experimental group will include hemodialysis patients hospitalized in the department of vascular surgery for acute AVF dysfunction, needing endovascular or open surgical revision for venous stenosis.
Blood will be withdrawn right before dialysis or surgical procedure. Plasma OPN will me measured by ELISA. Their clinical data would be collected from medical file at the same time. After the procedure, patients will be followed-up according to usual protocols.
To show a significant difference of 100ng/mL plasma OPN between the two groups, with a power of 90% and alpha risk of 0.05, we plan to include 76 patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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 under a social security scheme
- •Written informed consent obtain
- •18 years old or older
- •end-stage renal failure disease with 3 months dialysis minimum on a native arteriovenous fistula
- •Non-inclusion Criteria:
- •Subject under juridicial protection
- •Pregnant or lactating women
- •Subject already enrolled in a clinical trial involving a drug or an implantable medical device
排除标准
- •Withdrawal of consent
- •Investigator or sponsor decision
结局指标
主要结局
Plasmatic osteopontin level
时间窗: at inclusion
Plasmatic osteopontin level (ng/ml) collected in the patient's arteriovenous fistula. * Control arm: right before a dialysis session * Experimental arm: right before the surgery for stenosis of the fistula
次要结局
- Peripheral plasmatic osteopontin level in the contralateral arm(at inclusion)
