The Impact of Multi-drug Resistant Gram-negative Bacteria on Outcomes in Patients Requiring Veno-venous Extracorporeal Membrane Oxygenation (ECMO)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 279
- 试验地点
- 1
- 主要终点
- Incidence of MDR Gram negative bacteria acquired
研究概览
简要总结
Veno-venous extracorporeal membrane oxygenation (VV-ECMO) is a life-support technique used in patients with most severe acute respiratory distress syndrome (ARDS). ARDS is a life-threatening form of respiratory failure associated with a mortality rate of approximately 40-45%.Despite several studies confirming a real benefit of the use of ECMO in patients with ARDS who are unresponsive to conventional management, ECMO is still a complex and costly treatment that can be exposed to potential complications, such as nosocomial infections (NI).
详细描述
Noteworthy, the most frequent NIs occurring during VV-ECMO are pneumonia (>40%) and, secondly, blood-stream infections (3-18%). The situation is more challenging for Gram-negative bacilli: more than one-half of the Escherichia coli and more than one-third of the Klebsiella pneumoniae isolates were resistant to at least one antimicrobial group. Of note, an alarming increase in carbapenem resistance has been reported in several species, including K. pneumoniae (7.9% of isolates), P.aeruginosa (16.5% of isolates) and A. baumannii (>30% of isolates).
In fact, the isolation of MDROs has been shown to be an independent risk of death and of subsequent infections not only in critically ill patients but also in those patients requiring VV-ECMO (mortality rate between 56-68%). However, data are still conflicting about the exact incidence of multidrug resistant organisms (MDRO) during VV-ECMO and the impact on short- and mid-term outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- 未提供
排除标准
- •pregnancy
- •age < 18
- •uncompleted records
- •survival < 24h after ECMO connection
结局指标
主要结局
Incidence of MDR Gram negative bacteria acquired
时间窗: From ECMO connection up to 48 hours after ECMO de-connection
Incidence of MDR Gram negative bacteria acquired after ECMO connection (n° events/1.000 person-days of ECMO)
Overall incidence of MDR Gram negative bacteria isolations
时间窗: From ECMO connection up to 48 hours after ECMO de-connection
Overall incidence of MDR Gram negative bacteria isolations during ECMO (n° events/1.000 person-days of ECMO)
Incidence of MDR Gram negative bacteria isolated prior to ECMO connection
时间窗: At study enrollment
Incidence of patients requiring VV-ECMO with a previous MDR Gram negative bacteria
次要结局
- Incidence of MDR-related colonizations (plus descriptive analysis)(From ECMO connection up to 48 hours after ECMO de-connection)
- Incidence of MDR-related infections (plus descriptive analysis)(From ECMO connection up to 48 hours after ECMO de-connection)
- Risk factors-mortality(At ECMO connection (baseline))
研究者
Annalisa Boscolo
Co-investigator
University of Padova