Prognostic Interest of Vasorin in Septic Shock (VASO-SHOCK)

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).

Study Overview

• Status: Recruiting
• Conditions: Sepsis; Acute Kidney Injury
• Intervention / Treatment: Biological: Blood sampling

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julien Maizel, Pr; Phone Number: 0322087807; Email: Maizel.julien@chu-amiens.fr
• Study Contact Backup: Name: Pauline Caillard, MD; Phone Number: 0322087807; Email: Caillard.pauline@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80000
    • Recruiting
    • CHU Amiens-Picardie
    • Contact: Julien Maizel, Professor; Phone Number: +33 3 22 08 78 07; Email: maizel.julien@chu-amiens.fr
    • Sub-Investigator: Pauline Caillard, MD
    • Principal Investigator: Antoine Riviere, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
correlation between vasorin concentration at day 0 and mortality rate	day 0
correlation between vasorin concentration at day 3 and mortality rate	day 3

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: Centre Hospitalier Abbeville

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2023
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: October 3, 2023
• First Posted (Estimated): October 9, 2023

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Sepsis; Acute Kidney Injury; angiotensin II; vasorin
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Acute Kidney Injury
• Other Study ID Numbers: PI2023_843_0073

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No