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Completed

NCT Number: NCT03270358

OStéopontin as a Marker Of StenoSIS - 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Blood will be withdrawn right before dialysis or surgical procedure.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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice - Service de chirurgie vasculaire

Nice, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Blood sampling in arterioveinous fistula with stenosis

Procedure

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

Primary outcomes

  1. 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

  1. Peripheral plasmatic osteopontin level in the contralateral arm

    Time frame: at inclusion

    Peripheral plasmatic osteopontin level (ng/ml) collected in the contralateral arm (to measure the potential bias of a local osteopontin production in the fistula)

  2. Peripheral plasmatic osteopontin level in the contralateral arm

    Time frame: at inclusion

    Measure of the plasmatic osteopontin specificity and sensibility on the occurrence of a fistula stenosis (differents tresholds)

  3. Peripheral plasmatic osteopontin level in the contralateral arm

    Time frame: at inclusion

    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)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: OSMOSIS

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 1, 2017
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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