Diagnostic and Prognostic Evaluation of Vasorin During Septic Shock

NCT07203833 | Recruiting

• 1 other identifier: PI2025_843_0152
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vasorin; Septic Shock; Shock; Biomarker; Infection

Keywords

Septic shock; vasorin; Shock; Biomarker; Infection

Outcome Measures

Primary Outcomes (24)

• 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

Study Arms (2)

in septic shock (infection)

EXPERIMENTAL

Biological: blood sample

in shock without sepsis (without infection)

ACTIVE COMPARATOR

Biological: blood sample

Interventions

blood sample BIOLOGICAL

blood sample in order to measure the concentrations of circulating Vasn

in septic shock (infection); in shock without sepsis (without infection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens-Picardie

Amiens, 80000, France

RECRUITING

MeSH Terms

Conditions

Shock, Septic; Shock; Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Julien Maizel, Pr

CONTACT

33+322087807; maizel.julien@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: October 2, 2025
• Study Start: October 19, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)