OStéopontin as a Marker Of StenoSIS - OSMOSIS (OSMOSIS)
Primary Purpose
Stenosis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling in arterioveinous fistula without stenosis
Blood sampling in arterioveinous fistula with stenosis
Sponsored by
About this trial
This is an interventional basic science trial for Stenosis
Eligibility Criteria
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
Sites / Locations
- CHU de Nice - Service de chirurgie vasculaireRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
patient with stenosis
patient without stenosis
Arm Description
Patient coming to the vascular surgery unit to receive surgery regarding their fistula stenosis
Patient coming for their dialysis
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
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)
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)
Full Information
NCT ID
NCT03270358
First Posted
August 30, 2017
Last Updated
October 12, 2017
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT03270358
Brief Title
OStéopontin as a Marker Of StenoSIS - OSMOSIS
Acronym
OSMOSIS
Official Title
OStéopontin as a Marker Of StenoSIS - OSMOSIS
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 12, 2017 (Actual)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stenosis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patient with stenosis
Arm Type
Experimental
Arm Description
Patient coming to the vascular surgery unit to receive surgery regarding their fistula stenosis
Arm Title
patient without stenosis
Arm Type
Other
Arm Description
Patient coming for their dialysis
Intervention Type
Procedure
Intervention Name(s)
Blood sampling in arterioveinous fistula without stenosis
Intervention Description
Plasmatic osteopontin level (ng/ml) collected in the patient's arteriovenous fistula.
Blood sampling in arterioveinous fistula right before a dialysis session
Intervention Type
Procedure
Intervention Name(s)
Blood sampling in arterioveinous fistula with stenosis
Intervention Description
Blood sampling in arterioveinous fistula right before the surgery for stenosis of the fistula
Primary Outcome Measure Information:
Title
Plasmatic osteopontin level
Description
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
Time Frame
at inclusion
Secondary Outcome Measure Information:
Title
Peripheral plasmatic osteopontin level in the contralateral arm
Description
Peripheral plasmatic osteopontin level (ng/ml) collected in the contralateral arm (to measure the potential bias of a local osteopontin production in the fistula)
Time Frame
at inclusion
Title
Peripheral plasmatic osteopontin level in the contralateral arm
Description
Measure of the plasmatic osteopontin specificity and sensibility on the occurrence of a fistula stenosis (differents tresholds)
Time Frame
at inclusion
Title
Peripheral plasmatic osteopontin level in the contralateral arm
Description
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)
Time Frame
at inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nirvana SADAGHIANLOO
Phone
0492038548
Email
sadaghianloo.n@chu-nice.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julie CONTENTI
Email
contenti.j@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nirvana SADAGHIANLOO
Organizational Affiliation
sadaghianloo.n@chu-nice.fr
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nice - Service de chirurgie vasculaire
City
Nice
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nirvana Sadaghianloo, MD
Phone
04 92 03 38 35
Email
sadaghianloo.n@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Julie CONTENTI
12. IPD Sharing Statement
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OStéopontin as a Marker Of StenoSIS - OSMOSIS
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