Diagnostic and Prognostic Evaluation of Vasorin During Septic Shock

NCT ID: NCT07203833

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-19

Study Completion Date

2027-05-31

Brief Summary

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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

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Conditions

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Vasorin Septic Shock Shock Biomarker Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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in septic shock (infection)

Group Type EXPERIMENTAL

blood sample

Intervention Type BIOLOGICAL

blood sample in order to measure the concentrations of circulating Vasn

in shock without sepsis (without infection)

Group Type ACTIVE_COMPARATOR

blood sample

Intervention Type BIOLOGICAL

blood sample in order to measure the concentrations of circulating Vasn

Interventions

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blood sample

blood sample in order to measure the concentrations of circulating Vasn

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens-Picardie

Amiens, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Julien Maizel, Pr

Role: CONTACT

33+322087807

Facility Contacts

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Julien Maizel, Professor

Role: primary

+33 3 22 08 78 07

Other Identifiers

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PI2025_843_0152

Identifier Type: -

Identifier Source: org_study_id

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