OStéopontin as a Marker Of StenoSIS - OSMOSIS (OSMOSIS)

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Blood will be withdrawn right before dialysis or surgical procedure.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

Study Overview

• Status: Completed
• Conditions: Stenosis
• Intervention / Treatment: Procedure: Blood sampling in arterioveinous fistula with stenosis; Procedure: Blood sampling in arterioveinous fistula without stenosis

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nice, France
    • CHU de Nice - Service de chirurgie vasculaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

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

Exclusion Criteria:

• Withdrawal of consent
• Investigator or sponsor decision

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patient with stenosis; Patient coming to the vascular surgery unit to receive surgery regarding their fistula stenosis	Procedure: Blood sampling in arterioveinous fistula with stenosis; Blood sampling in arterioveinous fistula right before the surgery for stenosis of the fistula
Other: patient without stenosis; Patient coming for their dialysis	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasmatic osteopontin level	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	at inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripheral plasmatic osteopontin level in the contralateral arm	Peripheral plasmatic osteopontin level (ng/ml) collected in the contralateral arm (to measure the potential bias of a local osteopontin production in the fistula)	at inclusion
Peripheral plasmatic osteopontin level in the contralateral arm	Measure of the plasmatic osteopontin specificity and sensibility on the occurrence of a fistula stenosis (differents tresholds)	at inclusion
Peripheral plasmatic osteopontin level in the contralateral arm	Collection of comorbidity factors (diabetes, arterial hypertension, coronaropathy, overweight (BMI)), clinical factors (age and gender) and treatments at the time of patient's inclusion (anticoagulant, antisludge, antihypertensive drug, statins, erythropoietin)	at inclusion

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Nirvana SADAGHIANLOO, sadaghianloo.n@chu-nice.fr

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2018
• Primary Completion (Actual): September 17, 2019
• Study Completion (Actual): September 17, 2019

Study Registration Dates

• First Submitted: August 30, 2017
• First Submitted That Met QC Criteria: August 30, 2017
• First Posted (Actual): September 1, 2017

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: 17-AOI-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No