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The main purpose of this study is to compare the early detection of sepsis and the decision, by the Investigator to start or not, or to change, antibiotics in Intensive Care Unit (ICU) patients at high risk of sepsis, based on standard of care (clinical, laboratory and imaging data but not on PSP values), as well as timing of antibiotic de-escalation versus the the retrospective assessment (i.e., at the end of the study) of a First Endpoint Adjudication Committee (EAC) which is aware of the clinical data and of the PSP values but not of the Investigator's decision(s), and of the retrospective assessment of a Second Endpoint Adjudication Committee which is only aware of the PSP values.
This study will follow the site's routine clinical practice for the diagnostic, assessment and treatment of the enrolled patients, with the exception of daily blood samples which will be taken for the PSP measurement using the AbioScope as well as another daily sample taken for central analysis of biomarkers of inflammation, infection and/or sepsis (including but not limited to C-reactive protein [CRP] and Procalcitonin [PCT]).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Device | Daily blood samples which will be taken for the PSP measurement using the AbioScope as well as another daily sample taken for central analysis of biomarkers of inflammation, infection and/or sepsis (including but not limited to C-reactive protein [CRP] and Procalcitonin [PCT]). |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the performance of serial PSP values measured using the AbioScope. | i) To assess the performance of serial PSP values measured using the AbioScope in the early detection of sepsis in ICU patients at high risk of developing sepsis. | Day 1 to Day 30, or until discharge from ICU |
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Inclusion Criteria:
Exclusion Criteria:
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Critically ill patients at high risk of sepsis admitted to the ICU.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Le Mans, Service de Réanimation Médico Chirurgicale & USC | Le Mans | 72037 | France | |||
| CHU Limoges, Réanimation Polyvalente |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33879189 | Derived | Pugin J, Daix T, Pagani JL, Morri D, Giacomucci A, Dequin PF, Guitton C, Que YA, Zani G, Brealey D, Lepape A, Creagh-Brown B, Wyncoll D, Silengo D, Irincheeva I, Girard L, Rebeaud F, Maerki I, Eggimann P, Francois B. Serial measurement of pancreatic stone protein for the early detection of sepsis in intensive care unit patients: a prospective multicentric study. Crit Care. 2021 Apr 20;25(1):151. doi: 10.1186/s13054-021-03576-8. |
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| Limoges |
| 87042 |
| France |
| CH Lyon-Sud, Services de soins critiques | Pierre-Bénite | 69495 | France |
| Hôpital Bretonneau, CHU de Tours, Médecine Intensive - Réanimation | Tours | 37044 | France |
| Ospedale Santa Maria della Misericordia, Terapia Intensiva | Perugia | 6156 | Italy |
| Ospedale Santa Maria delle Croci, Terapia Intensiva | Ravenna | 48121 | Italy |
| Ospedale Infermi, Dept Anesthesia and ICU | Rimini | 47921 | Italy |
| Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione | Torino | 10154 | Italy |
| Bern University Hospital, Universitätsklinik für Intensivmedizin | Bern | 3010 | Switzerland |
| Hopitaux Universitaires de Genève, Service des soins intensifs, Département APSI | Geneva | 1205 | Switzerland |
| Centre Hospitalier Universitaire Vaudois, Service of Adult Intensive Care | Lausanne | 1011 | Switzerland |
| Royal Surrey County Hospital, Intensive Care Medicine | Guildford | GU2 7XX | United Kingdom |
| University College London Hospitals, Anaesthetics Department | London | NW1 2BU | United Kingdom |
| Guy's & St Thomas' Hospital, Department of Critical Care | London | SE1 7EH | United Kingdom |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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