Menu
Recruiting NCT07345169

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

— Observational Critical Illness Intensive Care Patients Critical Illness Requiring Intensive Care - Sepsis Critical Illness Requiring Intensive Care - Acute Brain Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Critical Illness, Intensive Care Patients, Critical Illness Requiring Intensive Care - Sepsis, Critical Illness Requiring Intensive Care - Acute Brain Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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).

Primary outcome measures

  • Overall survival of patients admitted to intensive care. [Time frame: 12 months]
  • Multidimensional flow cytometry leukocyte profiling [Time frame: Change from baseline to 12 months]
  • Inflammatory profile of ICU patients [Time frame: Change from baseline to 12 months]
Secondary outcome measures (2)
  • Change in SOFA Score [Time frame: Change from baseline to day 7]
  • Transcriptomic (scRNAseq) profiling of isolated leukocytes [Time frame: Change from baseline to12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • AP-HP Laribosière Hospital, Anesthesia and Critical Care Departement — Paris

Identifiers

NCT: NCT07345169 · APHP250001 · 2025-A00002-47

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗