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NCT Number: NCT07345169

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

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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Key information

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 Cross Infection Disease Attributes Iatrogenic Disease Infections Inflammation Intensive Care Patients Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AP-HP Laribosière Hospital, Anesthesia and Critical Care Departement

Paris, 75010, France

Location status: Recruiting

Location contact

Charles de Roquetaillade, MD

CONTACT

[email protected]

+33 (0)149958515

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overall survival of patients admitted to intensive care.

    Time frame: 12 months

    Difference in overall survival between ISU patients with different immunological and inflammatory profiles upon completion of the 12-month follow-up period.

  2. Multidimensional flow cytometry leukocyte profiling

    Time frame: 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

  3. Inflammatory profile of ICU patients

    Time frame: Change from baseline to 12 months

    Inflammation-related protein biomarkers will be analyzed using Olink assay

Secondary outcomes

  1. Change in SOFA Score

    Time frame: 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.

  2. Transcriptomic (scRNAseq) profiling of isolated leukocytes

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin Glenn Chousterman, MD PhD

CONTACT

[email protected]

+33 1 49 95 85 15

Charles de de Roquetaillade, MD

CONTACT

[email protected]

+33 1 49 95 85 15

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • European Society of Intensive Care Medicine
  • French Society for Intensive Care
  • INSERM U942
  • Société Française d'Anesthésie et de Réanimation
  • ZOLL Foundation, Fondation Les Gueules Cassées

Registry information

Official study title

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

Acronym: IMMUNOREA

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Jan 15, 2026
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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