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NCT Number: NCT07203833

Diagnostic and Prognostic Evaluation of Vasorin During Septic Shock

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.

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Key information

Conditions

Vasorin Biomarker Infection Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens-Picardie

Amiens, 80000, France

Location status: Recruiting

Location contact

Gaëlle Lenglet, PHD

SUB_INVESTIGATOR

Julien Maizel, Professor

CONTACT

[email protected]

+33 3 22 08 78 07

Osama Abou Arab, Pr

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample

Biological

blood sample in order to measure the concentrations of circulating Vasn

Primary outcomes

  1. Vasn plasma concentration at D0 for each group

    Time frame: day 0

  2. Vasn plasma concentration in each group

    Time frame: day 1

  3. Vasn plasma concentration in each group

    Time frame: day 3

  4. Correlation between Vasn plasma concentration and noradrenaline dose peak in each group

    Time frame: day 0

  5. Correlation between Vasn plasma concentration and noradrenaline dose peak in each group

    Time frame: day 1

  6. Correlation between Vasn plasma concentration and noradrenaline dose peak in each group

    Time frame: day 3

  7. Correlation between Vasn plasma concentration and occurrence of an IRA (KDIGO score) in each group

    Time frame: day 0

  8. Correlation between Vasn plasma concentration and occurrence of an IRA (KDIGO score) in each group

    Time frame: day 1

  9. Correlation between Vasn plasma concentration and occurrence of an IRA (KDIGO score) in each group

    Time frame: day 3

  10. Correlation between Vasn plasma concentration and coagulation marker concentration in each group

    Time frame: day 0

    coagulation marker are TF, platelet count, TP, TCA, Factor V, fibrinogen, D-dimers

  11. Correlation between Vasn plasma concentration and coagulation marker concentration in each group

    Time frame: day 1

    coagulation marker are TF, platelet count, TP, TCA, Factor V, fibrinogen, D-dimers

  12. Correlation between Vasn plasma concentration and coagulation marker concentration in each group

    Time frame: day 3

    coagulation marker are TF, platelet count, TP, TCA, Factor V, fibrinogen, D-dimers

  13. Correlation between Vasn plasma concentration and SOFA score at admission in each group

    Time frame: day 0

  14. Correlation between Vasn plasma concentration and SOFA score at admission in each group

    Time frame: day 1

  15. Correlation between Vasn plasma concentration and mortality in each group

    Time frame: day 3

  16. Correlation between Vasn plasma concentration and SOFA score at admission in each group

    Time frame: day 3

  17. Correlation between Vasn plasma concentration and mortality in each group

    Time frame: day 0

  18. Correlation between Vasn plasma concentration and mortality in each group

    Time frame: day 1

  19. Correlation between Vasn plasma concentration and length of hospitalization in each group

    Time frame: day 1

  20. Correlation between Vasn plasma concentration and length of hospitalization in each group

    Time frame: day 0

  21. Correlation between Vasn plasma concentration and length of hospitalization in each group

    Time frame: day 3

  22. Correlation between Vasn plasma concentration and plasma level of procalcitonin in each group

    Time frame: day 0

  23. Correlation between Vasn plasma concentration and plasma level of procalcitonin in each group

    Time frame: day 1

  24. Correlation between Vasn plasma concentration and plasma level of procalcitonin in each group

    Time frame: day 3

Study contacts

Contact information is provided by the study sponsor or research team.

Julien Maizel, Pr

CONTACT

[email protected]

33+322087807

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: VASO-DIAG

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 2, 2025
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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