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

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

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 Overview

• Status: Recruiting
• 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; Critical Illness Requiring Intensive Care - Polytrauma

• Study Type: Observational
• Enrollment (Estimated): 540

Contacts and Locations

• Study Contact: Name: Charles de de Roquetaillade, MD; Phone Number: +33 1 49 95 85 15; Email: charles.de-roquetaillade@aphp.fr
• Study Contact Backup: Name: Benjamin Glenn Chousterman, MD PhD; Phone Number: +33 1 49 95 85 15; Email: benjamin.chousterman@aphp.fr

Study Locations

• France
  • Paris, France, 75010
    • Recruiting
    • AP-HP Laribosière Hospital, Anesthesia and Critical Care Departement
    • Contact: Charles de Roquetaillade, MD; Phone Number: +33 (0)149958515; Email: charles.de-roquetaillade@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All adult patients (≥ 18 years old) admitted to intensive care.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: European Society of Intensive Care Medicine; French Society for Intensive Care; Société Française d'Anesthésie et de Réanimation; INSERM U942; ZOLL Foundation, Fondation Les Gueules Cassées

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): February 1, 2031
• Study Completion (Estimated): February 1, 2031

Study Registration Dates

• First Submitted: September 5, 2025
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Actual): January 15, 2026

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Inflammation; Prognosis; Immunology; Critical illness; Sepsis; Flow cytometry; Intensive care; Transcriptomics; scRNAseq; Nosocomial infections
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Systemic Inflammatory Response Syndrome; Iatrogenic Disease; Pathological Conditions, Signs and Symptoms; Critical Illness; Inflammation; Sepsis; Cross Infection
• Other Study ID Numbers: APHP250001; 2025-A00002-47 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data will be made available upon reasonable request, after publication of primary results, for research purposes only.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No