OStéopontin as a Marker Of StenoSIS - OSMOSIS

NCT03270358 | Completed

• 1 other identifier: 17-AOI-03
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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 Blood will be withdrawn right before dialysis or surgical procedure.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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Peripheral plasmatic osteopontin level in the contralateral arm

  at inclusion

• Peripheral plasmatic osteopontin level in the contralateral arm

  at inclusion

• Peripheral plasmatic osteopontin level in the contralateral arm

  at inclusion

Study Arms (2)

patient with stenosis

EXPERIMENTAL

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

Procedure: Blood sampling in arterioveinous fistula with stenosis

patient without stenosis

OTHER

Patient coming for their dialysis

Procedure: Blood sampling in arterioveinous fistula without stenosis

Interventions

Blood sampling in arterioveinous fistula without stenosis PROCEDURE

Plasmatic osteopontin level (ng/ml) collected in the patient's arteriovenous fistula. Blood sampling in arterioveinous fistula right before a dialysis session

patient without stenosis

Blood sampling in arterioveinous fistula with stenosis PROCEDURE

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

patient with stenosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients under a social security scheme
• Written informed consent obtain
• 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

You may not qualify if:

• Withdrawal of consent
• Investigator or sponsor decision

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice - Service de chirurgie vasculaire

Nice, France

Location

MeSH Terms

Conditions

Constriction, Pathologic

Interventions

Blood Specimen Collection; Constriction

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Nirvana SADAGHIANLOO

  sadaghianloo.n@chu-nice.fr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2017
• First Posted: September 1, 2017
• Study Start: February 8, 2018
• Primary Completion: September 17, 2019
• Study Completion: September 17, 2019
• Last Updated: November 15, 2023

Record last verified: 2023-11

Locations

FR (1)