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NCT Number: NCT07418801

Role of RNA Metabolism Alterations in Persistent Immune Dysfunction After Sepsis

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Anesthésie, Colombes, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Primary outcomes

  1. Longitudinal leukocyte transcriptomic endotype classification

    Time frame: From Day 1 to Month 12 after sepsis onset

    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.

Secondary outcomes

  1. Alternative splicing events in monocytes

    Time frame: From Day 1 to Month 12 after sepsis onset

    Differential splice variant expression in circulating monocytes, measured by RNA sequencing over time in sepsis and control patients.

  2. ICU length of stay

    Time frame: From ICU admission to ICU discharge

    Length of ICU stay, measured in days from ICU admission to ICU discharge.

  3. ICU mortality

    Time frame: From ICU admission to ICU discharge

    All-cause mortality during ICU stay, reported as % of patients.

  4. Nosocomial infections during ICU stay

    Time frame: From ICU admission to ICU discharge

    Percentage of patients with ≥1 nosocomial infection during ICU stay.

  5. Rehospitalizations within 12 months

    Time frame: From ICU discharge to 12 months after sepsis diagnosis

    Number of rehospitalizations for any cause within 12 months post-ICU discharge.

  6. New infectious episodes within 12 months

    Time frame: From ICU discharge to 12 months after sepsis diagnosis

    Percentage of patients with ≥1 new infectious episode within 12 months post-ICU discharge.

  7. Cardiovascular events within 12 months

    Time frame: From ICU discharge to 12 months after sepsis diagnosis

    Percentage of patients with ≥1 cardiovascular event (MI, stroke, heart failure) within 12 months post-ICU discharge.

  8. Incidence of clinical complications by longitudinal transcriptomic endotype

    Time frame: From Day 1 to Month 12 after sepsis onset

    Percentage of patients experiencing ≥1 predefined clinical complication according to longitudinal transcriptomic endotype membership.

  9. Genetic variants associated with longitudinal transcriptomic endotypes

    Time frame: From Day 1 to Month 12 after sepsis onset

    Frequency of selected genetic polymorphisms associated with longitudinal transcriptomic endotype membership, assessed using genome-wide genotyping arrays.

Study contacts

Contact information is provided by the study sponsor or research team.

Fabrice Uhel

CONTACT

[email protected]

01 47 60 61 93

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Rôle Des Altérations Du Métabolisme De L'ARN Dans La Persistance Des Perturbations Immunitaires Au Décours Du Sepsis

Acronym: SEPSI-splice

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 18, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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