NCT07345169

Brief 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). 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
540

participants targeted

Target at P75+ for all trials

Timeline
58mo left

Started Jan 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Jan 2026Feb 2031

First Submitted

Initial submission to the registry

September 5, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2031

Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

5.1 years

First QC Date

September 5, 2025

Last Update Submit

January 6, 2026

Conditions

Critical IllnessIntensive Care PatientsCritical Illness Requiring Intensive Care - Acute Brain InjuryCritical Illness Requiring Intensive Care - Major SurgeryCritical Illness Requiring Intensive Care - PolytraumaCritical Illness Requiring Intensive Care - Sepsis

Keywords

SepsisCritical illnessIntensive careImmunologyInflammationTranscriptomicsscRNAseqFlow cytometryNosocomial infectionsPrognosis

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Change in SOFA Score

    Change from baseline to day 7

  • Transcriptomic (scRNAseq) profiling of isolated leukocytes

    Change from baseline to12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Age ≥ 18 years
  • Admission to ICU within 24 hours

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AP-HP Laribosière Hospital, Anesthesia and Critical Care Departement

Paris, 75010, France

RECRUITING

MeSH Terms

Conditions

Critical IllnessSepsisInflammationCross Infection

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsInfectionsSystemic Inflammatory Response SyndromeIatrogenic Disease

Central Study Contacts

Charles de de Roquetaillade, MD

CONTACT

+33 1 49 95 85 15charles.de-roquetaillade@aphp.fr

Benjamin Glenn Chousterman, MD PhD

CONTACT

+33 1 49 95 85 15benjamin.chousterman@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2025

First Posted

January 15, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

February 1, 2031

Study Completion (Estimated)

February 1, 2031

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

De-identified individual participant data will be made available upon reasonable request, after publication of primary results, for research purposes only.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE

Locations

FR(1)