Diagnostic and Prognostic Evaluation of Vasorin During Septic Shock (VASO-DIAG)

Septic shock is the most severe form of infection. Currently, an early specific biomarker for septic shock is needed. Remember that shock situations are numerous, not only septic (eg hemorrhagic, cardiogenic...), and also accompanied by a severe pro-inflammatory state that it is sometimes difficult to distinguish from a septic state. Procalcitonin (PCT) is the most studied biomarker but still lacks sensitivity (77%) and specificity (79%). The investigators hypothesize that the Vasn could become this potential new biomarker and would allow a better diagnosis and thus the need or not to treat patients with antibiotics. The laboratory studies suggest a link between Vasn and septic shock. The goal of this project is to measure and compare plasma Vasn concentrations in 2 groups of patients = group 1: septic shock versus group 2: non-septic shock. Briefly, shock is defined as low blood pressure requiring vasopressor agents with confirmed infection (group 1) or without suspected infection such as patients admitted in intensive care unit post cardiac surgery with CBP (group 2). The investigators will also assess patient 28-day mortality to identify Vasn as a potential prognostic biomarker.

Study Overview

• Status: Recruiting
• Conditions: Shock; Septic Shock; Infection; Biomarker; Vasorin
• Intervention / Treatment: Biological: blood sample

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julien Maizel, Pr; Phone Number: 33+322087807; Email: maizel.julien@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: Osama Abou Arab, Pr
    • Sub-Investigator: Gaëlle Lenglet, PHD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Adults over 18 years.
• Patients admitted for less than 24 hours in intensive care unit of the CHU Amiens Picardie.
• Group 1: patients with septic shock defined by sepsis with 2 mmol/l Lactates, requiring vasopressors to maintain mean blood pressure at 65 mmHg (despite adequate vascular filling) in the presence of fever (T°>38.3) with a documented or suspected infection
• Group 2: patients with a shock defined by arterial hypotension requiring the use of vasopressors with 2 mmol/l Lactates but without suspected infection and apyrexie (T°<38°). For example: vasoplegia post cardiac surgery with CBP or cardiogenic shock or hemorrhagic shock

Exclusion Criteria:

• Pregnant women
• Group 1 : No evidence of suspected or documented infection
• Group 2 : Presence of fever and/or suspected infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: in septic shock (infection)	Biological: blood sample; blood sample in order to measure the concentrations of circulating Vasn
Active Comparator: in shock without sepsis (without infection)	Biological: blood sample; blood sample in order to measure the concentrations of circulating Vasn

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vasn plasma concentration at D0 for each group		day 0
Vasn plasma concentration in each group		day 1
Vasn plasma concentration in each group		day 3
Correlation between Vasn plasma concentration and noradrenaline dose peak in each group		day 0
Correlation between Vasn plasma concentration and noradrenaline dose peak in each group		day 1
Correlation between Vasn plasma concentration and noradrenaline dose peak in each group		day 3
Correlation between Vasn plasma concentration and occurrence of an IRA (KDIGO score) in each group		day 0
Correlation between Vasn plasma concentration and occurrence of an IRA (KDIGO score) in each group		day 1
Correlation between Vasn plasma concentration and occurrence of an IRA (KDIGO score) in each group		day 3
Correlation between Vasn plasma concentration and coagulation marker concentration in each group	coagulation marker are TF, platelet count, TP, TCA, Factor V, fibrinogen, D-dimers	day 0
Correlation between Vasn plasma concentration and coagulation marker concentration in each group	coagulation marker are TF, platelet count, TP, TCA, Factor V, fibrinogen, D-dimers	day 1
Correlation between Vasn plasma concentration and coagulation marker concentration in each group	coagulation marker are TF, platelet count, TP, TCA, Factor V, fibrinogen, D-dimers	day 3
Correlation between Vasn plasma concentration and SOFA score at admission in each group		day 0
Correlation between Vasn plasma concentration and SOFA score at admission in each group		day 1
Correlation between Vasn plasma concentration and mortality in each group		day 3
Correlation between Vasn plasma concentration and SOFA score at admission in each group		day 3
Correlation between Vasn plasma concentration and mortality in each group		day 0
Correlation between Vasn plasma concentration and mortality in each group		day 1
Correlation between Vasn plasma concentration and length of hospitalization in each group		day 1
Correlation between Vasn plasma concentration and length of hospitalization in each group		day 0
Correlation between Vasn plasma concentration and length of hospitalization in each group		day 3
Correlation between Vasn plasma concentration and plasma level of procalcitonin in each group		day 0
Correlation between Vasn plasma concentration and plasma level of procalcitonin in each group		day 1
Correlation between Vasn plasma concentration and plasma level of procalcitonin in each group		day 3

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: September 25, 2025
• First Submitted That Met QC Criteria: September 25, 2025
• First Posted (Estimated): October 2, 2025

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Biomarker; Infection; Shock; Septic shock; vasorin
• Additional Relevant MeSH Terms: Pathologic Processes; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Infections; Shock; Shock, Septic; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: PI2025_843_0152

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