Epidemiology and Outcomes of Gram Negative Urosepsis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 7
- 主要终点
- Number of patients with each causative pathogens and their susceptibility profile at the baseline evaluation (diagnosis of urosepsis)
研究概览
简要总结
The study aims to get an insight on the causative bacteria of sepsis derived from the urinary tract. Furthermore, it is the intention to understand the outcomes of these patients. For this purpose a non-interventional, observational study will be conducted.
详细描述
In this prospective, non-interventional, observational registry participants diagnosed with urosepsis will be registered to the study to capture the events and outcomes of interest. There will be no additional intervention and evaluation for the purpose of this study.
-Primary objectives:
- Pathogens: Causative pathogens and their susceptibility profile
- Clinical outcomes: Development of organ failure and mortality.
- Costs: Hospital resources used and costs acquired
- Secondary objective:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Microbiologically proven UTI
- •Patients must meet at least two of the following four SIRS criteria, at least one of which must be the core temperature criterion or the WBC criterion; these criteria did not have to be met simultaneously:
- •Hypothermia by core temperature <36ºC, or hyperthermia >38ºC measured via any means
- •Heart rate (HR) >90 beats per minute
- •Respiratory rate (RR) >20 breaths/minute related to septic event, or partial pressure of arterial carbon dioxide (PaCO2) <32 mmHg related to septic event or requiring mechanical ventilation related to septic event
- •Total WBC absolute count >12,000 cells/mm3 presence of granulocyte-stimulating factor, for those patients whose WBC absolute count was >12,000 cells/mm3 one other criterion (RR or HR) or <4000 cells/mm
- •In the , they must have had a fever and at least
排除标准
- •Sepsis due to other causes besides the urogenital tract.
结局指标
主要结局
Number of patients with each causative pathogens and their susceptibility profile at the baseline evaluation (diagnosis of urosepsis)
时间窗: initial diagnosis of urosepsis
Analysis results of microbiological cultures will be used to group them according to the definitions suggested by the ECDC as multi-drug resistant (MDR), extensive drug resistant (XDR) and pan-drug resistant (PDR).
次要结局
- Morbidity(First 30 days from diagnosis (baseline))
- Hospital Costs (Euros) of each patients Urosepsis management(Duration of Hospitalisation (basline evaluation to discharge of patient or death))
- Health related Quality of Life(Baseline, Follow-up (3rd, 7th, 9th and 30th day after baseline))
- All cause mortality(First 30 days from diagnosis)