Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-01-21 @ 3:32 AM
Study NCT ID:
NCT07203833
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-05
First Post:
2025-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic and Prognostic Evaluation of Vasorin During Septic Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2025-09-25', 'studyFirstSubmitQcDate': '2025-09-25', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vasn plasma concentration at D0 for each group', 'timeFrame': 'day 0'}, {'measure': 'Vasn plasma concentration in each group', 'timeFrame': 'day 1'}, {'measure': 'Vasn plasma concentration in each group', 'timeFrame': 'day 3'}, {'measure': 'Correlation between Vasn plasma concentration and noradrenaline dose peak in each group', 'timeFrame': 'day 0'}, {'measure': 'Correlation between Vasn plasma concentration and noradrenaline dose peak in each group', 'timeFrame': 'day 1'}, {'measure': 'Correlation between Vasn plasma concentration and noradrenaline dose peak in each group', 'timeFrame': 'day 3'}, {'measure': 'Correlation between Vasn plasma concentration and occurrence of an IRA (KDIGO score) in each group', 'timeFrame': 'day 0'}, {'measure': 'Correlation between Vasn plasma concentration and occurrence of an IRA (KDIGO score) in each group', 'timeFrame': 'day 1'}, {'measure': 'Correlation between Vasn plasma concentration and occurrence of an IRA (KDIGO score) in each group', 'timeFrame': 'day 3'}, {'measure': 'Correlation between Vasn plasma concentration and coagulation marker concentration in each group', 'timeFrame': 'day 0', 'description': 'coagulation marker are TF, platelet count, TP, TCA, Factor V, fibrinogen, D-dimers'}, {'measure': 'Correlation between Vasn plasma concentration and coagulation marker concentration in each group', 'timeFrame': 'day 1', 'description': 'coagulation marker are TF, platelet count, TP, TCA, Factor V, fibrinogen, D-dimers'}, {'measure': 'Correlation between Vasn plasma concentration and coagulation marker concentration in each group', 'timeFrame': 'day 3', 'description': 'coagulation marker are TF, platelet count, TP, TCA, Factor V, fibrinogen, D-dimers'}, {'measure': 'Correlation between Vasn plasma concentration and SOFA score at admission in each group', 'timeFrame': 'day 0'}, {'measure': 'Correlation between Vasn plasma concentration and SOFA score at admission in each group', 'timeFrame': 'day 1'}, {'measure': 'Correlation between Vasn plasma concentration and mortality in each group', 'timeFrame': 'day 3'}, {'measure': 'Correlation between Vasn plasma concentration and SOFA score at admission in each group', 'timeFrame': 'day 3'}, {'measure': 'Correlation between Vasn plasma concentration and mortality in each group', 'timeFrame': 'day 0'}, {'measure': 'Correlation between Vasn plasma concentration and mortality in each group', 'timeFrame': 'day 1'}, {'measure': 'Correlation between Vasn plasma concentration and length of hospitalization in each group', 'timeFrame': 'day 1'}, {'measure': 'Correlation between Vasn plasma concentration and length of hospitalization in each group', 'timeFrame': 'day 0'}, {'measure': 'Correlation between Vasn plasma concentration and length of hospitalization in each group', 'timeFrame': 'day 3'}, {'measure': 'Correlation between Vasn plasma concentration and plasma level of procalcitonin in each group', 'timeFrame': 'day 0'}, {'measure': 'Correlation between Vasn plasma concentration and plasma level of procalcitonin in each group', 'timeFrame': 'day 1'}, {'measure': 'Correlation between Vasn plasma concentration and plasma level of procalcitonin in each group', 'timeFrame': 'day 3'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Septic shock', 'vasorin', 'Shock', 'Biomarker', 'Infection'], 'conditions': ['Vasorin', 'Septic Shock', 'Shock', 'Biomarker', 'Infection']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults over 18 years.\n* Patients admitted for less than 24 hours in intensive care unit of the CHU Amiens Picardie.\n* 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\n* 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\n\nExclusion Criteria:\n\n* Pregnant women\n* Group 1 : No evidence of suspected or documented infection\n* Group 2 : Presence of fever and/or suspected infection'}, 'identificationModule': {'nctId': 'NCT07203833', 'acronym': 'VASO-DIAG', 'briefTitle': 'Diagnostic and Prognostic Evaluation of Vasorin During Septic Shock', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Diagnostic and Prognostic Evaluation of Vasorin During Septic Shock', 'orgStudyIdInfo': {'id': 'PI2025_843_0152'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'in septic shock (infection)', 'interventionNames': ['Biological: blood sample']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'in shock without sepsis (without infection)', 'interventionNames': ['Biological: blood sample']}], 'interventions': [{'name': 'blood sample', 'type': 'BIOLOGICAL', 'description': 'blood sample in order to measure the concentrations of circulating Vasn', 'armGroupLabels': ['in septic shock (infection)', 'in shock without sepsis (without infection)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80000', 'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens-Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}