Alterations of the Microbiome During Critical Illness With Short and Long Term Clinical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Long Term Mortality
研究概览
简要总结
This study is designed to study the variations in the microbiome among critically ill patients and the effect of admission to the medical intensive care unit (MICU) at the University of Chicago. Additionally, investigators will examine the downstream clinical effects of dysbiosis in ICU patients and how patients maybe effected long term.
详细描述
During this study investigators will longitudinally collect discarded stool biosamples throughout the MICU admission when available. Stool Bio specimens will be recorded/coded and processed by the investigators. Stool Bio specimens will be analyzed for 16sRNA and metabolomics. Surveys will be conducted at study entry, in addition to 6 months and 12 months following discharge.
By longitudinally sampling discarded biospecimens from subjects throughout their MICU admission in additionally to describing long term following up. We will be able to correlate changes in the microbiome with clinical data, and follow up surveys to identify factors that may impact the composition of the microbiome and their impact on clinical outcomes.
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
- •adult patients admitted to the intensive care unit
排除标准
- 未提供
结局指标
主要结局
Long Term Mortality
时间窗: up to 1 year
Death from any cause 90 day, 1 year
次要结局
- Cognitive Dysfunction(Up to 12 months after discharge)
- Functional Status Score(up to 12 months after discharge)
- Hospital length of stay(hospitalization up to 6 weeks)
- hospital mortality(28 day)
- ICU length of stay(hospitalization up to 6 weeks)
- Quality of Life score(up to 12 months after discharge)