VasorinVASO-DIAGNCT07203833
Diagnostic and Prognostic Evaluation of Vasorin During Septic Shock
A study testing blood sample in people with Vasorin and Septic Shock, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vasorin, Septic Shock, Shock
- What is being tested?
- blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteFrance
- Study dates
- 19 Oct 2025to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant women
- Group 1 : No evidence of suspected or documented infection
- Group 2 : Presence of fever and/or suspected infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens-Picardie
Amiens, 80000
Julien Maizel, Professor, +33 3 22 08 78 07, maizel.julien@chu-amiens.fr
Gaëlle Lenglet, PHD
About this study
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.
- Conditions
- Vasorin, Septic Shock, Shock, Biomarker, Infection
- Being tested
- blood sample
- Keywords
- Septic shock, vasorin, Shock, Biomarker, Infection
- Medical subject headings
- Shock, Septic, Shock, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleBiological
blood sample in order to measure the concentrations of circulating Vasn
| Study group | Role | What they receive |
|---|---|---|
| in septic shock (infection) | Experimental | Not described Receives: Biological: blood sample |
| in shock without sepsis (without infection) | Active comparator | Not described Receives: Biological: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vasn plasma concentration at D0 for each group
Measured: day 0
Vasn plasma concentration in each group
Measured: day 1
Vasn plasma concentration in each group
Measured: day 3
Correlation between Vasn plasma concentration and noradrenaline dose peak in each group
Measured: day 0
Correlation between Vasn plasma concentration and noradrenaline dose peak in each group
Measured: day 1
Correlation between Vasn plasma concentration and noradrenaline dose peak in each group
Measured: day 3
Correlation between Vasn plasma concentration and occurrence of an IRA (KDIGO score) in each group
Measured: day 0
Correlation between Vasn plasma concentration and occurrence of an IRA (KDIGO score) in each group
Measured: day 1
Correlation between Vasn plasma concentration and occurrence of an IRA (KDIGO score) in each group
Measured: day 3
Correlation between Vasn plasma concentration and coagulation marker concentration in each group
coagulation marker are TF, platelet count, TP, TCA, Factor V, fibrinogen, D-dimers
Measured: day 0
Correlation between Vasn plasma concentration and coagulation marker concentration in each group
coagulation marker are TF, platelet count, TP, TCA, Factor V, fibrinogen, D-dimers
Measured: day 1
Correlation between Vasn plasma concentration and coagulation marker concentration in each group
coagulation marker are TF, platelet count, TP, TCA, Factor V, fibrinogen, D-dimers
Measured: day 3
Correlation between Vasn plasma concentration and SOFA score at admission in each group
Measured: day 0
Correlation between Vasn plasma concentration and SOFA score at admission in each group
Measured: day 1
Correlation between Vasn plasma concentration and mortality in each group
Measured: day 3
Correlation between Vasn plasma concentration and SOFA score at admission in each group
Measured: day 3
Correlation between Vasn plasma concentration and mortality in each group
Measured: day 0
Correlation between Vasn plasma concentration and mortality in each group
Measured: day 1
Correlation between Vasn plasma concentration and length of hospitalization in each group
Measured: day 1
Correlation between Vasn plasma concentration and length of hospitalization in each group
Measured: day 0
Correlation between Vasn plasma concentration and length of hospitalization in each group
Measured: day 3
Correlation between Vasn plasma concentration and plasma level of procalcitonin in each group
Measured: day 0
Correlation between Vasn plasma concentration and plasma level of procalcitonin in each group
Measured: day 1
Correlation between Vasn plasma concentration and plasma level of procalcitonin in each group
Measured: day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start19 Oct 2025
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VasorinStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203833
- Sponsor's protocol ID
- PI2025_843_0152
- Acronym
- VASO-DIAG
- Status last verified
- Jan 2026
- First submitted
- 25 Sep 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Prognostic Evaluation of Vasorin During Septic Shock
- ClinicalTrials.gov ID
- NCT07203833
- Acronym / sponsor ID
- VASO-DIAG / PI2025_843_0152
- Conditions
- Vasorin, Septic Shock, Shock, Biomarker, Infection
- Keywords
- Septic shock, vasorin, Shock, Biomarker, Infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 19 Oct 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| in septic shock (infection) | Experimental | Biological: blood sample |
| in shock without sepsis (without infection) | Active comparator | Biological: blood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnant women
- Group 1 : No evidence of suspected or documented infection
- Group 2 : Presence of fever and/or suspected infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sampleblood sample in order to measure the concentrations of circulating Vasn | Biological | in septic shock (infection), in shock without sepsis (without infection) |
Primary outcome
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
coagulation marker are TF, platelet count, TP, TCA, Factor V, fibrinogen, D-dimers
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
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
Correlation between Vasn plasma concentration and SOFA score at admission in each group
Time frame: day 0
Correlation between Vasn plasma concentration and SOFA score at admission in each group
Time frame: day 1
Correlation between Vasn plasma concentration and mortality in each group
Time frame: day 3
Correlation between Vasn plasma concentration and SOFA score at admission in each group
Time frame: day 3
Correlation between Vasn plasma concentration and mortality in each group
Time frame: day 0
Correlation between Vasn plasma concentration and mortality in each group
Time frame: day 1
Correlation between Vasn plasma concentration and length of hospitalization in each group
Time frame: day 1
Correlation between Vasn plasma concentration and length of hospitalization in each group
Time frame: day 0
Correlation between Vasn plasma concentration and length of hospitalization in each group
Time frame: day 3
Correlation between Vasn plasma concentration and plasma level of procalcitonin in each group
Time frame: day 0
Correlation between Vasn plasma concentration and plasma level of procalcitonin in each group
Time frame: day 1
Correlation between Vasn plasma concentration and plasma level of procalcitonin in each group
Time frame: day 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample in people with Vasorin and Septic Shock, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julien Maizel, Pr (33+322087807, maizel.julien@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vasn plasma concentration at D0 for each group (time frame: day 0). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.