Diagnostic and Prognostic Evaluation of Vasorin During Septic Shock

Not Applicable

Not yet recruiting

• Conditions: Vasorin; Septic Shock; Shock; Infection; Biomarker
• Interventions: Biological: blood sample

• Registration Number: NCT07203833
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-25
• Study First Submitted QC: 2025-09-25
• Last Update Submitted: 2025-09-25
• Study Start: 2025-10-01
• Study First Posted: 2025-10-02
• Last Update Posted: 2025-10-02
• Primary Completion: 2027-04
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 144

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
in septic shock (infection)	blood sample	-
in shock without sepsis (without infection)	blood sample	-

Primary Outcome Measures

Name	Time	Method
Vasn plasma concentration at D0 for each group	day 0
Vasn plasma concentration in each group	day 3
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 3
Correlation between Vasn plasma concentration and coagulation marker concentration in each group	day 3	coagulation marker are TF, platelet count, TP, TCA, Factor V, fibrinogen, D-dimers
Correlation between Vasn plasma concentration and mortality in each group	day 1
Correlation between Vasn plasma concentration and SOFA score at admission in each group	day 3
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 3

Trial Locations

Locations (1)

CHU Amiens-Picardie; 🇫🇷 Amiens, France