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临床试验/NCT03270358
NCT03270358已完成不适用

OStéopontin as a Marker Of StenoSIS - OSMOSIS

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2018年2月8日最近更新:
适应症

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Blood will be withdrawn right before dialysis or surgical procedure.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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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