NCT04979767Unknown不适用
Function of Circulating Exosomes in Sepsis-induced Immunosuppression
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 28-day mortality
研究概览
简要总结
This is a single-center prospective bio-specimen analysis and observational study aiming to define immune pathways disrupted in bacterial sepsis and to identify clinically useful biomarkers of immune status.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 50 years with ≥ 2 chronic comorbidities
- •Highly suspected bacterial infection based on clinical or radiologic evidence
- •≥ 2 systemic inflammatory response syndrome (SIRS) criteria
- •Actual/anticipated admission to intensive care unit (ICU)
- •Anticipated length of hospital stay ≥ 5 days
排除标准
- •Pregnancy
- •Underlying immunosuppression (solid organ transplant, hematopoietic stem cell transplant, neutropenia, HIV infection, long-term corticosteroid use (≥ 20 mg prednisone equivalents for ≥ 14 days), immunosuppressants, radiation, chemotherapy, immune-modifying biologics, viral hepatitis, or systemic autoimmune diseases)
- •Current immunotherapy use
- •Confirmed COVID-19 infection
结局指标
主要结局
28-day mortality
时间窗: From enrollment to 28 days
All-cause mortality
次要结局
- Duration of infection(From enrollment until resolution of SIRS, up to 90 days)
- Hospital mortality(From enrollment until hospital discharge, up to 90 days)
- 90-day mortality(From enrollment to 90 days)
- Length of stay(From enrollment until hospital discharge, up to 90 days)
研究者
Nicholas Britt
Assistant Professor
University of Kansas Medical Center
研究点 (1)
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