Role of RNA Metabolism Alterations in Persistent Immune Dysfunction After Sepsis
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: Sepsis. Basic parameters: No limits · 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 →
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Official title
Rôle Des Altérations Du Métabolisme De L'ARN Dans La Persistance Des Perturbations Immunitaires Au Décours Du Sepsis
Overview
This study includes adult ICU patients with sepsis (according to SEPSIS 3.0) or critically ill non-septic patients with severe non-infectious conditions at Louis Mourier Hospital. It is a prospective multicentre observational study aiming to describe leukocyte transcriptome changes and molecular trajectories (endotypes) during the acute, recovery, and convalescence phases of sepsis. A total of 290 participants will be included: 200 septic patients, 50 critically ill non-septic patients, and 40 control participants.
Detailed description
The study will be a prospective, multicentre, observational study including adult ICU patients hospitalized with sepsis (according to SEPSIS 3.0 definitions) or critically ill non-septic patients with severe non-infectious conditions at Louis Mourier Hospital.
Participants will be assigned to one of three groups:
* Septic patients group: 200 patients with suspected or documented infection and a SOFA score ≥2. * Critically ill non-septic patients group: 50 patients without infection and a SOFA score ≥2. * Control group: 40 ambulatory participants without infection, matched for age and sex.
Blood samples for transcriptome and immunomonitoring analyses will be collected at predefined time points during ICU stay and post-ICU follow-up (J1, J3, J7, J14, M3, M6, M12). Routine clinical and laboratory parameters will also be recorded.
The primary objective is to describe longitudinal molecular trajectories (endotypes) of circulating leukocytes over the natural course of sepsis. The primary endpoint is the identification of molecular endotypes from sequential transcriptome analyses.
Secondary analyses will compare molecular profiles between septic and non-septic patients, evaluate the effects of alternative splicing on the cellular proteome, and correlate endotypes with clinical outcomes during ICU stay and up to 12 months post-inclusion. Bioinformatic methods (JLCMM, KmL) and pathway analysis (Ingenuity Pathway Analysis, Qiagen) will be used to identify patient groups with similar molecular profiles over time.
Primary outcome measures
- Longitudinal leukocyte transcriptomic endotype classification [Time frame: From Day 1 to Month 12 after sepsis onset]
Secondary outcome measures (9)
- Alternative splicing events in monocytes [Time frame: From Day 1 to Month 12 after sepsis onset]
- ICU length of stay [Time frame: From ICU admission to ICU discharge]
- ICU mortality [Time frame: From ICU admission to ICU discharge]
- Nosocomial infections during ICU stay [Time frame: From ICU admission to ICU discharge]
- Rehospitalizations within 12 months [Time frame: From ICU discharge to 12 months after sepsis diagnosis]
- New infectious episodes within 12 months [Time frame: From ICU discharge to 12 months after sepsis diagnosis]
- Cardiovascular events within 12 months [Time frame: From ICU discharge to 12 months after sepsis diagnosis]
- Incidence of clinical complications by longitudinal transcriptomic endotype [Time frame: From Day 1 to Month 12 after sepsis onset]
- Genetic variants associated with longitudinal transcriptomic endotypes [Time frame: From Day 1 to Month 12 after sepsis onset]
Eligibility criteria
\- Septic patients group: Age ≥ 18 years Hospitalized in Intensive Care Medicine Suspected or confirmed infection SOFA score ≥ 2
\- Critically ill non-septic patients group: Age ≥ 18 years Hospitalized in Intensive Care Medicine No infection (neither suspected nor confirmed) SOFA score ≥ 2
\- Healthy control group Age ≥ 18 years Ambulatory patient (not hospitalized) No infection at the time of consultation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
France · 2 centers
- Anesthésie — Colombes
- Médecine Intensive Réanimation -Hôpital Louis Mourier — Colombes
Identifiers
NCT: NCT07418801 · APHP251573 · 2025-A02505-44