An observational study in Critical Illness, Intensive Care Patients and Critical Illness Requiring Intensive Care - Sepsis, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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).
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's planned enrollment of 540 is above the median of 130 across 867 observational studies indexed under Critical Illness.
Browse Critical Illness studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All adult patients (≥ 18 years old) admitted to intensive care.
Exclusion Criteria:
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.
Time frame: 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
Time frame: Change from baseline to 12 months
Inflammatory profile of ICU patients
Inflammation-related protein biomarkers will be analyzed using Olink assay
Time frame: Change from baseline to 12 months
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.
Time frame: Change from baseline to day 7
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
Time frame: Change from baseline to12 months
Plan to share: Yes — De-identified individual participant data will be made available upon reasonable request, after publication of primary results, for research purposes only.
Supporting information: Study protocol, Sap, Icf, Analytic code
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Assistance Publique - Hôpitaux de Paris