Medical Education for Sepsis Source Control and Antibiotics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,138
- 试验地点
- 42
- 主要终点
- All-cause mortality
研究概览
简要总结
Patients with severe sepsis or septic shock suffer from life-threatening infections. Fast and adequate therapy with antibiotics is crucial for survival. Current guidelines recommend the application of broad-spectrum antibiotics within 1 hour after diagnosis. However, recent studies showed that such treatment is delayed for several hours.
In this study, medical staff of participating hospitals is trained to achieve a duration until antimicrobial therapy of less than 1 hour. Tools of change management are used. The data are compared to a control group (hospitals without intervention).
It is hypothesized that a multifaceted educational program decreases duration until antimicrobial therapy and improves survival.
详细描述
This study is a cluster randomized trial (CRT) where the hospitals are the clusters. 44 hospitals in Germany have confirmed their participation. Hospitals are randomized into two groups: a control and an interventional group. The control group receives conventional CMEs. The interventional group receives tools for increasing awareness such as posters and brochures. Quality measure such as benchmarking and feedback of quality indicators are used. Depending on the improvement process tools such as SWOT analyses and resistance radar will be implemented.
The CRT was preceded by a 5 months observational study (Dec. 2010 - April 2011). In about 1000 patients, participating hospitals documented their patients with severe sepsis or septic shock into a register. These data are used for final sample size calculation of the CRT and for stratification of the randomization.
The groups switch after completion of the CRT and observation continues. Thus, centers of the control group now receive the change management while the former intervention group is now without external support and is assessed for sustainability of the intervention. This study phase is planned for Nov. 2013 until March 2015. Sample size will be calculated when the CRT has been finished.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For the hospitals (cluster):
- •Involved in the primary care of patients with severe sepsis/septic shock
- •Willing to participate in a guideline implementation process
- •For the patients:
- •New onset of suspicion of severe sepsis or septic shock in the following settings:
- •Prehospital
- •Emergency department
- •Operating theatre
- •Regular ward
- •Intensive care unit (ICU)/Intermediate Care Unit (IMC)
排除标准
- •For the hospitals (cluster):
- •No intensive care unit available
- •no acute care for patients with severe sepsis and septic shock
- •For the patients:
- •Start of sepsis therapy in a non-study site
- •Patients not admitted to the ICU/IMC
- •No commitment to full medical support (i.e. DNR)
研究组 & 干预措施
Intervention group
干预措施: Change Management (Behavioral)
Conventional CME
Hospitals receive conventional continuing medical education in lecture style twice a year. They receive current publications and recommendations for national and international meetings regarding diagnosis and therapy of sepsis.
结局指标
主要结局
All-cause mortality
时间窗: 28 days
次要结局
- Duration until antimicrobial therapy
- Duration until focus control
- Fraction of patients with antimicrobial therapy within 1 hour
- ICU and hospital mortality
- ICU and and hospital length of stay
- Frequency of blood cultures
- Frequency of adequate antimicrobial therapy
研究者
Frank Bloos
Lead investigator of the MEDUSA study group
Center for Sepsis Control and Care, Germany