Abdominal SepsiS Study: Epidemiology of Etiology and Outcome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,200
- 试验地点
- 1
- 主要终点
- Clinical response
研究概览
简要总结
The aim of the project is to perform a multinational, prospective, observational study on IAIs (IntraAbdominal Infections) in critically ill patients; special emphasis will be given to epidemiology and outcomes.
详细描述
To investigate microbiology and/or drug resistance patterns related to: Geographical region, Source of IAI, Upper GI tract perforation (stomach & duodenum), Lower GI tract perforation (jejunum, ileum, colon, rectum), Primary peritonitis, Peritoneal dialysis-related peritonitis, Intra-abdominal abscess, Pancreatic infection, Biliary tract infection, Typhlitis, Toxic megacolon.
To check the Origin of IAI: community-acquired, early-onset healthcare-associated, late-onset healthcare-associated.
To describe physician's antimicrobial prescription patterns related to a classification grid that stratifies IAIs according to disease expression, community or healthcare origin, and anatomical disruption.
To investigate outcomes (clinical response, need for surgical revision, length of hospitalization, and mortality) related to: Classification of IAI, Severity of acute illness at time of diagnosis (SOFA score) and clinical response after 48-72 hrs. (SOFA score), Processes of care (Time to 1st antimicrobial dose, Time to source control, Type of source control intervention (laparotomy, percutaneous drainage, high volume peritoneal lavage, restoration of anatomy and function), Need for (unplanned) surgical revision (uncontrolled infection source), Frequency of microbiological sampling and delay of results)), Pathogens involved and empirical antimicrobial coverage; special emphasis will be given, to coverage of multidrug resistant Enterobacteriaceae, Pseudomonas aeruginosa, enterococci and Candida species, Duration of antimicrobial therapy, Underlying conditions
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
- •Adult (≥18 yrs. of age)
- •IAI treated with percutaneous or surgical procedure
- •ICU admission (the patient should either be admitted to the ICU because of abdominal sepsis or should be admitted in the ICU for other reasons and subsequently developed abdominal sepsis as a complication during the ICU course)
- •Informed consent (if required by local ethics committee)
排除标准
- 未提供
结局指标
主要结局
Clinical response
时间窗: Clinical response at 7 days
次要结局
- Surgical revision(within the first week)
- Length of hospitalization(up to 6 months)
- Mortality(During the 6 month study period)
