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OStéopontin as a Marker Of StenoSIS - OSMOSIS

NCT03270358 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2023-11-15

No results posted yet for this study

Summary

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Blood will be withdrawn right before dialysis or surgical procedure.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

Conditions

  • Stenosis

Interventions

PROCEDURE

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

PROCEDURE

Blood sampling in arterioveinous fistula with stenosis

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nice

    lead OTHER

Principal Investigators

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-08
Primary Completion
2019-09-17
Completion
2019-09-17

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03270358 on ClinicalTrials.gov