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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A02505-44 | Registry Identifier | IDRCB |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Septic Patients | Adult ICU patients hospitalized with sepsis according to SEPSIS 3.0 definitions. Inclusion criteria: age ≥ 18 years, suspected or documented infection, and SOFA score ≥ 2. No specific intervention; observational study collecting clinical and biological data including leukocyte transcriptome analyses. | ||
| Critically Ill Non-Septic Patients | Adult ICU patients hospitalized with severe non-infectious conditions, without infection. Inclusion criteria: age ≥ 18 years, SOFA score ≥ 2. No specific intervention; observational study collecting clinical and biological data including leukocyte transcriptome analyses. | ||
| Control Patients | Ambulatory adult patients (not hospitalized) without infection at the time of consultation. Inclusion criteria: age ≥ 18 years. No specific intervention; blood samples will be collected for transcriptome and immunomonitoring analyses. |
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| Measure | Description | Time Frame |
|---|---|---|
| Longitudinal leukocyte transcriptomic endotype classification | Classification of patients into longitudinal leukocyte transcriptomic endotypes based on sequential circulating leukocyte RNA sequencing. Endotype membership will be determined using transcriptomic profiling and reported as categorical group assignment over time, including comparison with critically ill non-infected control patients. | From Day 1 to Month 12 after sepsis onset |
| Measure | Description | Time Frame |
|---|---|---|
| Alternative splicing events in monocytes | Differential splice variant expression in circulating monocytes, measured by RNA sequencing over time in sepsis and control patients. | From Day 1 to Month 12 after sepsis onset |
| ICU length of stay |
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- 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
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Adult patients hospitalized in the ICU at Louis Mourier Hospital with either sepsis according to SEPSIS 3.0 criteria or a severe non-infectious condition. The study also includes a healthy ambulatory control group without infection.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fabrice Uhel | Contact | 01 47 60 61 93 | fabrice.uhel@aphp.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anesthésie | Colombes | France | ||||
| Médecine Intensive Réanimation -Hôpital Louis Mourier |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D003289 | Convalescence |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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Blood samples will be collected from all participants for research-specific analyses, including plasma, RNA, and DNA extraction.
For septic and critically ill non-septic patients:
For control participants:
- At inclusion [J1]: collected during pre-anesthesia consultation and routine blood tests .
All additional blood volumes for research will be drawn only during routine clinical blood sampling, ideally via an existing arterial catheter if available. No extra venipuncture will be performed solely for research purposes.
These biospecimens will be retained for future molecular and immunological analyses, including extraction of DNA and RNA, after obtaining informed consent from participants.
Length of ICU stay, measured in days from ICU admission to ICU discharge.
| From ICU admission to ICU discharge |
| ICU mortality | All-cause mortality during ICU stay, reported as % of patients. | From ICU admission to ICU discharge |
| Nosocomial infections during ICU stay | Percentage of patients with ≥1 nosocomial infection during ICU stay. | From ICU admission to ICU discharge |
| Rehospitalizations within 12 months | Number of rehospitalizations for any cause within 12 months post-ICU discharge. | From ICU discharge to 12 months after sepsis diagnosis |
| New infectious episodes within 12 months | Percentage of patients with ≥1 new infectious episode within 12 months post-ICU discharge. | From ICU discharge to 12 months after sepsis diagnosis |
| Cardiovascular events within 12 months | Percentage of patients with ≥1 cardiovascular event (MI, stroke, heart failure) within 12 months post-ICU discharge. | From ICU discharge to 12 months after sepsis diagnosis |
| Incidence of clinical complications by longitudinal transcriptomic endotype | Percentage of patients experiencing ≥1 predefined clinical complication according to longitudinal transcriptomic endotype membership. | From Day 1 to Month 12 after sepsis onset |
| Genetic variants associated with longitudinal transcriptomic endotypes | Frequency of selected genetic polymorphisms associated with longitudinal transcriptomic endotype membership, assessed using genome-wide genotyping arrays. | From Day 1 to Month 12 after sepsis onset |
| Colombes |
| France |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |