跳至主要内容
临床试验/NCT02165501
NCT02165501Unknown不适用

Jena Sepsis Registry - a Sepsis-registry for Long Term Outcomes

University of Jena1 个研究点 分布在 1 个国家目标入组 1,995 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,995
试验地点
1
主要终点
all cause mortality

研究概览

简要总结

Despite the burden of severe sepsis and septic shock deficiencies in the quality of sepsis management are recognized. Investigators present a population-based registry with easy feasibility as part of German Center for Sepsis Control & Care (CSCC). All ICU patients of the Jena University Hospital, Germany will be screened for inclusion (severe sepsis or septic shock). Baseline data on ICU- and hospital care will be extracted from patient records at ICU discharge. The primary outcome is change in all-cause mortality from baseline to follow up at 6, 12, 24, 36, 48 and 60 months after diagnosis of sepsis. Follow-up data will be collected from the primary care provider of the patient. The registry may provide valid data on quality in sepsis care.

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

  • Patients treated in one of the ICUs will be enrolled if they were 18 years or older and fulfill the diagnostic criteria of severe sepsis or septic shock (ICD-10-GM, R65.0, R65.1) (19), (20).
  • Diagnosis of severe sepsis or septic shock requires the following criteria: a microbiologically documented and/or clinically evident infection, at least two of the four criteria of the systemic inflammatory response syndrome (SIRS) and at least one new organ dysfunction, remote from the site of infection.

排除标准

  • 未提供

结局指标

主要结局

all cause mortality

时间窗: change from baseline to 6,12, 24, 36, 48 and 60 months after ICU discharge

based on data from hospital records as well as patient records of the primary care provider.

次要结局

未报告次要终点

研究者

发起方
University of Jena
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jochen Gensichen, MD, MA, MPH

Professor and Chair

Jena University Hospital

研究点 (1)

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