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Diagnostic and Prognostic Evaluation of Vasorin During Septic Shock

Diagnostic and Prognostic Evaluation of Vasorin During Septic Shock

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07203833
Acronym
VASO-DIAG
Enrollment
144
Registered
2025-10-02
Start date
2025-10-19
Completion date
2027-05-31
Last updated
2026-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biomarker, Infection, Septic Shock, Shock, Vasorin

Keywords

Septic shock, vasorin, Shock, Biomarker, Infection

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.

Interventions

BIOLOGICALblood sample

blood sample in order to measure the concentrations of circulating Vasn

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Countries

France

Contacts

Primary ContactJulien Maizel, Pr
maizel.julien@chu-amiens.fr33+322087807

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026