Studies on the Immunological and Inflammatory Determinants Associated With the Prognosis of Patients Admitted to Intensive Care
概览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- Overall survival of patients admitted to intensive care.
概览
简要总结
This is a prospective observational physiopathological study aimed at evaluating the immunological and inflammatory determinants associated with the prognosis of patients admitted to intensive care units (ICU). The study will establish multidimensional models predicting one-year survival and the occurrence of nosocomial infections.
Patients admitted to ICU undergo routine biological sampling. In addition to these, minimal supplementary samples will be collected for immunological and inflammatory biomarker analysis at admission, day 1, day 4, day 8, ICU discharge or day 28, and at 12 months. Additional samples may be taken during clinically significant events (nosocomial infections, complications).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Admission to ICU within 24 hours
排除标准
- •Moribund patient (ECOG=4)
- •Legal protection (guardianship/curatorship)
- •Uninsured patients
- •Pre-existing immunosuppression (active/recent cancer, hematologic disease, autoimmune disease, organ transplant, HIV)
- •Pregnant or breastfeeding women
- •Participation in another interventional trial
- •Patients under AME
结局指标
主要结局
Overall survival of patients admitted to intensive care.
时间窗: 12 months
Difference in overall survival between ISU patients with different immunological and inflammatory profiles upon completion of the 12-month follow-up period.
Multidimensional flow cytometry leukocyte profiling
时间窗: Change from baseline to 12 months
The isolated cell samples will be analyzed to determine the absolute number and percentage of B cells, monocytes, CD4+ and CD8+ T cells, CD3+CD56+ NKT cells, and NK cells
Inflammatory profile of ICU patients
时间窗: Change from baseline to 12 months
Inflammation-related protein biomarkers will be analyzed using Olink assay
次要结局
- Change in SOFA Score(Change from baseline to day 7)
- Transcriptomic (scRNAseq) profiling of isolated leukocytes(Change from baseline to12 months)