Mitochondrial DNA as a Biomarker of Sepsis Severity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,304
- 试验地点
- 2
- 主要终点
- Hospital Mortality
研究概览
简要总结
Mitochondria are organelles (a specialized subunit of a cell) responsible for providing cells with energy. For reasons not yet understood, mitochondria will release their DNA into blood in response to cellular injury or cell death.
With a simple blood draw, investigators can measure the amount of mitochondrial DNA in a patient's blood.
The investigators' hypothesis, is that mitochondrial DNA can be used as a surrogate marker of cellular injury to predict patient outcomes. The investigators intend to test their hypothesis by measuring mitochondrial DNA in adult patients presenting to the Emergency Department with sepsis (a life-threatening condition due to an infection) and observing their hospital course.
详细描述
Despite the advances of modern medicine, sepsis persists as one of the leading causes of death in the United States and poses a significant burden on U.S. health care, accounting for more than $24 billion of total hospital costs in 2013. The high mortality and cost of treating sepsis at least partially stems from the consequences of delayed diagnosis. Unfortunately, this delay is attributable to the broad clinical manifestations of the syndrome and the absence of a specific test for sepsis.
Realizing this, The Society of Critical Care Medicine and the European Society of Intensive Care Medicine have released guidelines emphasizing the need for diagnostic approaches aimed at the early detection of sepsis. The hope is that early recognition will allow for more aggressive upfront management thereby improving patient outcomes.
In 2013, Nakahira et al showed that circulating cell-free mitochondrial DNA levels are associated with sepsis and mortality in patients admitted to the ICU. In contrast to that study, the purpose here is to determine whether circulating cell-free mitochondrial DNA and other biomarkers are associated with the severity of sepsis and 28-day mortality in patients presenting to the ED with sepsis.
To accomplish this task, the investigators intend to prospectively collect specimens from patients presenting to NYP-Weill Cornell and NYP-Brooklyn Methodist with suspected sepsis.
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
- •Adults presenting to the Emergency Department with suspected sepsis.
排除标准
- •Pregnancy.
- •Patients with limitations of care at the time of specimen collection.
结局指标
主要结局
Hospital Mortality
时间窗: 60 Days
All-Cause
次要结局
- Association with severity of illness as determined by qSOFA Score(3 Days)
- Association with severity of illness severity of illness as determined by MEDS Score(3 Days)
- Association with severity of illness as determined by SOFA Score(3 Days)
- Need for Supportive Measures(Up to 60 Days)
- ICU-Free Days(28 Days)
- Triage Decision(3 Days)