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

Studies on the Immunological and Inflammatory Determinants Associated With the Prognosis of Patients Admitted to Intensive Care

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07345169

Acronym

IMMUNOREA

Enrollment

540

Registered

2026-01-15

Start date

2026-01-31

Completion date

2031-02-28

Last updated

2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Sepsis, Critical illness, Intensive care, Immunology, Inflammation, Transcriptomics, scRNAseq, Flow cytometry, Nosocomial infections, Prognosis

Brief summary

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Overall survival of patients admitted to intensive care.	12 months	Difference in overall survival between ISU patients with different immunological and inflammatory profiles upon completion of the 12-month follow-up period.
Multidimensional flow cytometry leukocyte profiling	Change from baseline to 12 months	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
Inflammatory profile of ICU patients	Change from baseline to 12 months	Inflammation-related protein biomarkers will be analyzed using Olink assay

Secondary

Measure	Time frame	Description
Change in SOFA Score	Change from baseline to day 7	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.
Transcriptomic (scRNAseq) profiling of isolated leukocytes	Change from baseline to12 months	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

Countries

France

Contacts

Primary ContactCharles de de Roquetaillade, MD

charles.de-roquetaillade@aphp.fr+33 1 49 95 85 15

Backup ContactBenjamin Glenn Chousterman, MD PhD

benjamin.chousterman@aphp.fr+33 1 49 95 85 15

Outcome results