Critical IllnessIMMUNOREANCT07345169
IMMUNOREA - Immunological and Inflammatory Determinants Associated With the Prognosis of Intensive Care Patients
An observational study of Critical Illness and Intensive Care Patients, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Intensive Care Patients, Critical Illness Requiring Intensive Care - Sepsis
- How many people
- 540 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2026to Feb 2031
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients (≥ 18 years old) admitted to intensive care.
Who may be able to join
- Age ≥ 18 years
- Admission to ICU within 24 hours
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
AP-HP Laribosière Hospital, Anesthesia and Critical Care Departement
Paris, 75010
Charles de Roquetaillade, MD, +33 (0)149958515, charles.de-roquetaillade@aphp.fr
About this study
Official title: 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).
- 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
- Keywords
- Sepsis, Critical illness, Intensive care, Immunology, Inflammation, Transcriptomics, scRNAseq, Flow cytometry, Nosocomial infections, Prognosis
- Medical subject headings
- Critical Illness, Sepsis, Inflammation, Cross Infection
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Change from baseline to 12 months
Inflammatory profile of ICU patients
Inflammation-related protein biomarkers will be analyzed using Olink assay
Measured: Change from baseline to 12 months
Secondary outcomes (2)
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.
Measured: 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
Measured: Change from baseline to12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start2 Feb 2026
- Primary completionFeb 2031 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM U942, Société Française d'Anesthésie et de Réanimation, French Society for Intensive Care, European Society of Intensive Care Medicine, ZOLL Foundation, Fondation Les Gueules Cassées
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345169
- Sponsor's protocol ID
- APHP250001
- Other IDs
- 2025-A00002-47
- Acronym
- IMMUNOREA
- Status last verified
- Oct 2026
- First submitted
- 5 Sep 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be made available upon reasonable request, after publication of primary results, for research purposes only.