Rôle Des Altérations Du Métabolisme De L'ARN Dans La Persistance Des Perturbations Immunitaires Au Décours Du Sepsis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 290
- 试验地点
- 2
- 主要终点
- Longitudinal leukocyte transcriptomic endotype classification
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- 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
排除标准
- 未提供
研究组 & 干预措施
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.
结局指标
主要结局
Longitudinal leukocyte transcriptomic endotype classification
时间窗: 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.
次要结局
- 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)
- New infectious episodes within 12 months(From ICU discharge to 12 months after sepsis diagnosis)
- Cardiovascular events within 12 months(From ICU discharge to 12 months after sepsis diagnosis)
- Incidence of clinical complications by longitudinal transcriptomic endotype(From Day 1 to Month 12 after sepsis onset)
- Genetic variants associated with longitudinal transcriptomic endotypes(From Day 1 to Month 12 after sepsis onset)