Prognostic Interest of Vasorin in Septic Shock (VASO-SHOCK)
Primary Purpose
Sepsis, Acute Kidney Injury
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling
Sponsored by
About this trial
This is an interventional other trial for Sepsis focused on measuring vasorin, Sepsis, angiotensin II, Acute Kidney Injury
Eligibility Criteria
Inclusion Criteria: Age ≥18 years old. Hospitalized in intensive care or medical resuscitation units. With a septic shock state defined by 2 mmol/l lactate sepsis, requiring vasopressors to maintain mean blood pressure 65 mmHg (despite adequate vascular filling). Whether or not they have developed AKI. Patient/family information and collection of non opposition Exclusion Criteria: Patients with chronic respiratory failure. Pregnant women. Patients in palliative care. Information for the patient/someone close and collection of his opposition
Sites / Locations
- CHU Amiens-PicardieRecruiting
Outcomes
Primary Outcome Measures
correlation between vasorin concentration at day 0 and mortality rate
correlation between vasorin concentration at day 3 and mortality rate
Secondary Outcome Measures
Full Information
NCT ID
NCT06072508
First Posted
October 3, 2023
Last Updated
October 3, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
Centre Hospitalier Abbeville
1. Study Identification
Unique Protocol Identification Number
NCT06072508
Brief Title
Prognostic Interest of Vasorin in Septic Shock
Acronym
VASO-SHOCK
Official Title
Prognostic Interest of Vasorin in Septic Shock
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 3, 2023 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
Centre Hospitalier Abbeville
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
In septic shock, the intensity and duration of low blood pressure can lead to a critical reduction in renal tissue perfusion and lead to the onset of more or less severe Acute Kidney Injury (AKI). Vasorin (Vasn) is a protein strongly expressed in large vessels and kidneys, whose functions are still poorly known. Previous experimental studies show that Vasn is associated with decreased Angiotensin II concentrations, a vessel contractility defect and early mortality.
The investigators hypothesize that Vasn (the potential direct regulator of blood pressure) would be an early biomarker predicting the severity of AKI post septic shock, which may be associated with mortality from septic shock or lead to longer-term Chronic Renal Failure (CKD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Acute Kidney Injury
Keywords
vasorin, Sepsis, angiotensin II, Acute Kidney Injury
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Blood sampling
Intervention Description
Blood sampling (at day 0 and day 3) for Vasn, Angiotensin 2 and clotting markers.
Primary Outcome Measure Information:
Title
correlation between vasorin concentration at day 0 and mortality rate
Time Frame
day 0
Title
correlation between vasorin concentration at day 3 and mortality rate
Time Frame
day 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years old.
Hospitalized in intensive care or medical resuscitation units.
With a septic shock state defined by 2 mmol/l lactate sepsis, requiring vasopressors to maintain mean blood pressure 65 mmHg (despite adequate vascular filling).
Whether or not they have developed AKI.
Patient/family information and collection of non opposition
Exclusion Criteria:
Patients with chronic respiratory failure.
Pregnant women.
Patients in palliative care.
Information for the patient/someone close and collection of his opposition
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julien Maizel, Pr
Phone
0322087807
Email
Maizel.julien@chu-amiens.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Pauline Caillard, MD
Phone
0322087807
Email
Caillard.pauline@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens-Picardie
City
Amiens
ZIP/Postal Code
80000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien Maizel, Professor
Phone
+33 3 22 08 78 07
Email
maizel.julien@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Pauline Caillard, MD
First Name & Middle Initial & Last Name & Degree
Antoine Riviere, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prognostic Interest of Vasorin in Septic Shock
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