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

ConditionsCritical IllnessIntensive Care PatientsCritical Illness Requiring Intensive Care - SepsisCritical Illness Requiring Intensive Care - Acute Brain InjuryCritical Illness Requiring Intensive Care - Major SurgeryCritical Illness Requiring Intensive Care - Polytrauma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Admission to ICU within 24 hours

Disqualifiers

Moribund patient (ECOG=4)

Legal protection (guardianship/curatorship)

Uninsured patients

Pre-existing immunosuppression (active/recent cancer, hematologic disease, autoimmune disease, organ transplant, HIV)

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months
2

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

Time frame
Change from baseline to 12 months
3

Inflammatory profile of ICU patients

Inflammation-related protein biomarkers will be analyzed using Olink assay

Time frame
Change from baseline to 12 months

Secondary outcomes

1

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.

Time frame
Change from baseline to day 7
2

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

Time frame
Change from baseline to12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

INSERM U942

Collaborator

Société Française d'Anesthésie et de Réanimation

Collaborator

French Society for Intensive Care

Collaborator

European Society of Intensive Care Medicine

Collaborator

ZOLL Foundation, Fondation Les Gueules Cassées

Collaborator

Source ClinicalTrials.gov
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