跳至主要内容
临床试验/NCT02930070
NCT02930070Unknown不适用

Diagnostic Accuracy of qSOFA Score for the Diagnosis of Sepsis in General Wards: a Single Center Cohort Study

Peking Union Medical College Hospital2 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
4,000
试验地点
2
主要终点
28-day mortality

研究概览

简要总结

The new definition of sepsis (sepsis 3.0) restricts the early diagnosis of sepsis in general wards. Despite an alternative process by using a simplified qSOFA score, many patients may still be left out. Whether these patients matter or not is unknown. This prospective cohort includes patients from ten general wards with high incidence of infection during a consecutive half year, obtains qSOFA and SOFA score, follows up prognostic data, therefore to compare patients under different groups, eventually to evaluate the diagnostic accuracy of qSOFA score in diagnosis of sepsis.

详细描述

The sepsis, which is considered as multi-organ dysfunction induced by infection, is a one of leading causes of death in hospital. In 2016, the third international consensus has modified the definition of sepsis from infection with >=2 of systemic inflammatory response syndrome (SIRS) criteria to infection with >=2 of sequential organ failure assessment (SOFA) score. This new definition, which well reflects the organ dysfunction nature of sepsis, however makes it difficult to diagnose sepsis in general wards. An alternative of process was put forward to compensate this weakness. For each infection patient in general, access a quick SOFA (qSOFA), if it is above 2 score, then conduct laboratory examination to get a SOFA score. This process is helpful to find out sepsis, but undoubtedly leave out some patients who meet the SOFA criteria without qSOFA >=2. Besides, there are also some patients who has a qSOFA >=2 however do not meet the SOFA criteria. Whether those patients have better survival rate is unclear. This prospective cohort is aimed to compare prognosis of patients with different SOFA, qSOFA score, therefore access the diagnostic accuracy of qSOFA in the diagnosis of sepsis, eventually evaluate the feasibility of using qSOFA as a complete replacement of SOFA in general wards.

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

入选标准

  • Age>=18;

排除标准

  • Hospital stay less than 24h just for chemotherapy,biotherapy or endoscopy.

结局指标

主要结局

28-day mortality

时间窗: 28 day

the mortality within 28 day of hospital stay

次要结局

  • Organ dysfunctions(28 day)
  • Duration of stay in the hospital(28 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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