Role of RNA Metabolism Alterations in Persistent Immune Dysfunction After Sepsis

NCT07418801 | Not Yet Recruiting

• 2 other identifiers: APHP2515732025-A02505-44
• Study Type: observational
• Target: 290
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Sepsis

Keywords

Sepsis; Endotypes; Molecular trajectories; Transcriptomics; Leukocytes; Acute phase; Recovery phase; Convalescence

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• Alternative splicing events in monocytes

  From Day 1 to Month 12 after sepsis onset

• ICU length of stay

  From ICU admission to ICU discharge

• ICU mortality

  From ICU admission to ICU discharge

• Nosocomial infections during ICU stay

  From ICU admission to ICU discharge

• Rehospitalizations within 12 months

  From ICU discharge to 12 months after sepsis diagnosis

Study Arms (3)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

\- 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Anesthésie

Colombes, France

Location

Médecine Intensive Réanimation -Hôpital Louis Mourier

Colombes, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

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: * Acute phase in ICU \[J1\] : Collected during routine daily blood draws * Recovery phase in ICU \[J3, J7, J14\]: Collected during routine blood draws * Convalescence phase post-ICU \[M3, M6, M12\]: collected during follow-up visits 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.

MeSH Terms

Conditions

Sepsis; Convalescence

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Central Study Contacts

Fabrice Uhel

CONTACT

01 47 60 61 93; fabrice.uhel@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 48 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 18, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)