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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A00002-47 | Other Identifier | IDRCB |
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| Name | Class |
|---|---|
| INSERM U942 | UNKNOWN |
| Société Française d'Anesthésie et de Réanimation | OTHER |
| French Society for Intensive Care | OTHER |
| European Society of Intensive Care Medicine |
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This is a prospective observational physiopathological study aimed at evaluating the immunological and inflammatory determinants associated with the prognosis of patients admitted to intensive care units (ICU). The study will establish multidimensional models predicting one-year survival and the occurrence of nosocomial infections.
Patients admitted to ICU undergo routine biological sampling. In addition to these, minimal supplementary samples will be collected for immunological and inflammatory biomarker analysis at admission, day 1, day 4, day 8, ICU discharge or day 28, and at 12 months. Additional samples may be taken during clinically significant events (nosocomial infections, complications).
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival of patients admitted to intensive care. | Difference in overall survival between ISU patients with different immunological and inflammatory profiles upon completion of the 12-month follow-up period. | 12 months |
| Multidimensional flow cytometry leukocyte profiling | The isolated cell samples will be analyzed to determine the absolute number and percentage of B cells, monocytes, CD4+ and CD8+ T cells, CD3+CD56+ NKT cells, and NK cells | Change from baseline to 12 months |
| Inflammatory profile of ICU patients | Inflammation-related protein biomarkers will be analyzed using Olink assay | Change from baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in SOFA Score | Sequential Organ Failure Assessment (SOFA) Score included the degree of dysfunction of six organ systems (Respiratory, Cardiovascular, Liver, Renal, Coagulation, Neurologic). Minimum score = 0 maximum score = 24. Higher scores indicate greater degree of dysfunction. | Change from baseline to day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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All adult patients (≥ 18 years old) admitted to intensive care.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charles de de Roquetaillade, MD | Contact | +33 1 49 95 85 15 | charles.de-roquetaillade@aphp.fr | |
| Benjamin Glenn Chousterman, MD PhD | Contact | +33 1 49 95 85 15 | benjamin.chousterman@aphp.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HP Laribosière Hospital, Anesthesia and Critical Care Departement | Recruiting | Paris | 75010 | France |
De-identified individual participant data will be made available upon reasonable request, after publication of primary results, for research purposes only.
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| OTHER |
| ZOLL Foundation, Fondation Les Gueules Cassées | UNKNOWN |
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| Transcriptomic (scRNAseq) profiling of isolated leukocytes |
Change in the transcriptome of leukocytes isolated from blood, bronchoalveolar lavage fluid (BAL), cerebrospinal fluid (CSF), urine, and tissues, as measured by single cell RNA-sequencing using Flex technology |
| Change from baseline to12 months |
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D018805 | Sepsis |
| D007249 | Inflammation |
| D003428 | Cross Infection |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007049 | Iatrogenic Disease |
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