IMMUNOREA - Immunological and Inflammatory Determinants Associated With the Prognosis of Intensive Care Patients

Assistance Publique - Hôpitaux de Paris540 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

540

Conditions

Critical Illness Intensive Care Patients Critical Illness Requiring Intensive Care - Sepsis Critical Illness Requiring Intensive Care - Acute Brain Injury Critical Illness Requiring Intensive Care - Major Surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years * Admission to ICU within 24 hours Exclusion Criteria: * Moribund patient (ECOG=4) * Legal protection (guardianship/curatorship) * Uninsured patients * Pre-existing immunosuppression (active/recent cancer, hematologic disease, autoimmune disease, organ transplant, HIV) * Pregnant or breastfeeding women * Participation in another interventional trial * Patients under AME

Outcomes

Primary Outcomes

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

Secondary Outcomes

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