Menu
Recruiting NCT07203833

Diagnostic and Prognostic Evaluation of Vasorin During Septic Shock

No phase Interventional Vasorin Septic Shock Shock Biomarker

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: blood sample.
Who it may be relevant to
Registry conditions: Vasorin, Septic Shock, Shock, Biomarker. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Biological blood sample
    blood sample in order to measure the concentrations of circulating Vasn

Primary outcome measures

  • Vasn plasma concentration at D0 for each group [Time frame: day 0]
  • Vasn plasma concentration in each group [Time frame: day 1]
  • Vasn plasma concentration in each group [Time frame: day 3]
  • Correlation between Vasn plasma concentration and noradrenaline dose peak in each group [Time frame: day 0]
  • Correlation between Vasn plasma concentration and noradrenaline dose peak in each group [Time frame: day 1]
  • Correlation between Vasn plasma concentration and noradrenaline dose peak in each group [Time frame: day 3]
  • Correlation between Vasn plasma concentration and occurrence of an IRA (KDIGO score) in each group [Time frame: day 0]
  • Correlation between Vasn plasma concentration and occurrence of an IRA (KDIGO score) in each group [Time frame: day 1]
  • Correlation between Vasn plasma concentration and occurrence of an IRA (KDIGO score) in each group [Time frame: day 3]
  • Correlation between Vasn plasma concentration and coagulation marker concentration in each group [Time frame: day 0]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • CHU Amiens-Picardie — Amiens

Identifiers

NCT: NCT07203833 · PI2025_843_0152

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗