Effect of a multifaceted educational intervention for anti-infectious measures on sepsis mortality: a cluster randomized trial
Effect of a multifaceted educational intervention for anti-infectious measures on sepsis mortality: a cluster randomized trial
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DOI：
10.1007/s00134-017-4782-4
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发表时间：
2017-11-01
影响因子：
38.9
通讯作者：
Reinhart, Konrad
中科院分区：
文献类型：
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作者：
Bloos, Frank;Rueddel, Hendrik;Reinhart, Konrad
目的：指南建议在脓毒症确诊后1小时内给予抗生素，但这一建议尚未通过随机试验进行验证。本试验的目的是调查生存是否改善，通过减少前开始抗菌治疗的时间，通过多方面的干预，在遵守指南recommendations.Methods：MEDUSA研究，前瞻性多中心随机分组试验，进行了从2011年7月至2013年7月在40家德国医院。医院被随机分配接受传统的持续医学教育（CME）措施（对照组）或多方面的干预措施，包括当地质量改进团队，教育推广，审计，反馈和提醒。我们纳入了4183例严重脓毒症或脓毒性休克患者，进行意向治疗分析，比较多方面干预（n = 2596）与传统CME（n = 1587）。结果：干预组28天死亡率为35.1%（883/2596例），对照组为26.7%（403/1587例; p = 0.01）。干预不是死亡率的风险因素，因为这种差异从研究开始就存在，并且不受干预的影响。干预组至抗生素治疗的中位时间为1.5 h（四分位距0.1-4.9 h），对照组为2.0 h（0.4-5.9 h; p = 0.41）。死亡的风险增加了2%每小时延迟的抗菌治疗和1%每小时延迟的源控制，独立组assignment.Conclusions：延迟抗菌治疗和源控制与死亡率增加，但多方面的方法是无法改变的时间，抗菌治疗在这种情况下，并不影响生存。
Purpose: Guidelines recommend administering antibiotics within 1 h of sepsis recognition but this recommendation remains untested by randomized trials. This trial was set up to investigate whether survival is improved by reducing the time before initiation of antimicrobial therapy by means of a multifaceted intervention in compliance with guideline recommendations.Methods: The MEDUSA study, a prospective multicenter cluster-randomized trial, was conducted from July 2011 to July 2013 in 40 German hospitals. Hospitals were randomly allocated to receive conventional continuous medical education (CME) measures (control group) or multifaceted interventions including local quality improvement teams, educational outreach, audit, feedback, and reminders. We included 4183 patients with severe sepsis or septic shock in an intention-to-treat analysis comparing the multifaceted intervention (n = 2596) with conventional CME (n = 1587). The primary outcome was 28-day mortality.Results: The 28-day mortality was 35.1% (883 of 2596 patients) in the intervention group and 26.7% (403 of 1587 patients; p = 0.01) in the control group. The intervention was not a risk factor for mortality, since this difference was present from the beginning of the study and remained unaffected by the intervention. Median time to antimicrobial therapy was 1.5 h (interquartile range 0.1-4.9 h) in the intervention group and 2.0 h (0.4-5.9 h; p = 0.41) in the control group. The risk of death increased by 2% per hour delay of antimicrobial therapy and 1% per hour delay of source control, independent of group assignment.Conclusions: Delay in antimicrobial therapy and source control was associated with increased mortality but the multifaceted approach was unable to change time to antimicrobial therapy in this setting and did not affect survival.