OStéopontin as a Marker Of StenoSIS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-08

Study Completion Date

2019-09-17

Brief Summary

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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Blood will be withdrawn right before dialysis or surgical procedure.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

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Detailed Description

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Conditions

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Stenosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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patient with stenosis

Patient coming to the vascular surgery unit to receive surgery regarding their fistula stenosis

Group Type EXPERIMENTAL

Blood sampling in arterioveinous fistula with stenosis

Intervention Type PROCEDURE

Blood sampling in arterioveinous fistula right before the surgery for stenosis of the fistula

patient without stenosis

Patient coming for their dialysis

Group Type OTHER

Blood sampling in arterioveinous fistula without stenosis

Intervention Type PROCEDURE

Plasmatic osteopontin level (ng/ml) collected in the patient's arteriovenous fistula.

Blood sampling in arterioveinous fistula right before a dialysis session

Interventions

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Blood sampling in arterioveinous fistula without stenosis

Plasmatic osteopontin level (ng/ml) collected in the patient's arteriovenous fistula.

Blood sampling in arterioveinous fistula right before a dialysis session

Intervention Type PROCEDURE

Blood sampling in arterioveinous fistula with stenosis

Blood sampling in arterioveinous fistula right before the surgery for stenosis of the fistula

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

* Subject under juridicial protection
* Pregnant or lactating women
* Subject already enrolled in a clinical trial involving a drug or an implantable medical device