OStéopontin as a Marker Of StenoSIS - OSMOSIS
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Plasmatic osteopontin level
Study Overview
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Blood will be withdrawn right before dialysis or surgical procedure.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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
patient with stenosis
Patient coming to the vascular surgery unit to receive surgery regarding their fistula stenosis
Intervention: Blood sampling in arterioveinous fistula with stenosis (Procedure)
patient without stenosis
Patient coming for their dialysis
Intervention: Blood sampling in arterioveinous fistula without stenosis (Procedure)
Outcomes
Primary Outcomes
Plasmatic osteopontin level
Time Frame: 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
Secondary Outcomes
- Peripheral plasmatic osteopontin level in the contralateral arm(at inclusion)