Jena Sepsis Registry - a Sepsis-registry for Long Term Outcomes
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
- 否
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
Jochen Gensichen, MD, MA, MPH
Professor and Chair
Jena University Hospital
