Evaluation of the Potential Impact of Computerized Antimicrobial Stewardship on the Antimicrobial Use After Cardiovascular Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,473
- 试验地点
- 1
- 主要终点
- DOT per 1000 patient-days (PD)
研究概览
简要总结
This trial is an open-label, two-arm, cluster-randomized, controlled trial with cardiovascular surgical teams as the unit of randomization. Eligible teams with written consent are randomized to the intervention or control arm by random number generator. Computer-based, multicomponent intervention targeting on reduction of perioperative antimicrobial use will be delivered to teams in the intervention arm. Teams in the control arm will continue with usual clinical care.
详细描述
The aim of the EPIC trial is to assess if a multicomponent computer-based system incorporated into the workflow can reduce days of therapy (DOT) per admission after cardiovascular surgeries in the intervention surgical teams compared with controlled surgical teams, over a one-year period. This trial is an open-label, two-arm, cluster-randomized, controlled trial with cardiovascular surgical teams as the unit of randomization. Eligible teams with written consent are randomized to the intervention or control arm by random number generator. Computer-based, multicomponent intervention targeting on reduction of perioperative antimicrobial use will be delivered to teams in the intervention arm. Teams in the control arm will continue with usual clinical care. The intervention includes re-evaluation alerts and decision support for the duration of antimicrobial treatment, re-evaluation alerts and decision support for the choice of antimicrobial, and quality control audit and feedback. Nine teams per arm with an average size of 1125 admissions will be recruited. Primary outcome will be the overall systemic antibiotic use measured in DOT of systemic antibiotic use per admission. Secondary outcomes include a series of indices to evaluate antimicrobial use, microbial resistance, perioperative infection outcomes, patient safety, resource consumption and user compliance/satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Over 18 years of age;
- •Receiving at least one open-chest cardiovascular surgery during the same admission.
排除标准
- •Intravenous or oral antimicrobial use within two weeks before surgery;
- •Emergent/urgent surgery;
- •Admitted for isolated stenting or heart transplantation or implantation of ventricular assist device or implantation of extracorporeal membrane oxygenation;
- •Admitted for subacute bacterial endocarditis;
- •Length of ICU stay over 48 hours.
结局指标
主要结局
DOT per 1000 patient-days (PD)
时间窗: From the date of admission to the date of discharge, assessed up to 60 days.
DOT per 1000 patient-days
Days of antimicrobial therapy (DOT) per admission
时间窗: From the date of admission to the date of discharge, assessed up to 3 months.
DOT represents a specific antibiotic administered to an individual patient on a calendar day independent of dose and route.
次要结局
- Length of therapy (LOT) per 100 PD(From the date of admission to the date of discharge, assessed up to 60 days.)
- Drug usage (DDDs) per 100 PD(From the date of admission to the date of discharge, assessed up to 60 days.)
- Rate of participants with clostridium difficile colitis(From the date of admission to the date of discharge, assessed up to 60 days.)
- Incident clinical cultures with multidrug resistant organisms (MRSA, ESBL-E, CRE, VRE, or Pseudomonas aeruginosa) per 1000 PD and admission.(From the date of admission to the date of discharge, assessed up to 60 days.)
- Drug usage (DDDs) per admission(From the date of admission to the date of discharge, assessed up to 60 days.)
- Rate of in-hospital pneumonia(From the date of admission to the date of discharge, assessed up to 60 days.)
- User compliance with the system(From the date of inclusion of the first patient to the date of discharge of the last patient, assessed up to 12 months.)
- Days per treatment period overall and for specific indications(From the date of admission to the date of discharge, assessed up to 60 days.)
- In-hospital or 30-day surgical site infections (SSIs)(30 days from accomplished of the surgery.)
- Rate of in-hospital bloodstream infections(From the date of admission to the date of discharge, assessed up to 60 days.)
- Length of therapy (LOT) per admission(From the date of admission to the date of discharge, assessed up to 60 days.)
- Costs of administered antimicrobials (overall and by class) per admission(From the date of admission to the date of discharge, assessed up to 60 days.)
- In-hospital or 30-day mortality, postoperative(30 days from accomplished of the surgery or within hospital.)
- In-hospital or 30-day myocardial infarction (MI), postoperative and newly onset(30 days from accomplished of the surgery or within hospital.)
- Length of hospital stay (LOS)(From the date of admission to the date of discharge, assessed up to 60 days.)
- In-hospital or 30-day stroke, postoperative and newly onset(30 days from accomplished of the surgery or within hospital)
- In-hospital or 30-day acute kidney injury (AKI) , postoperative and newly onset(30 days from accomplished of the surgery or within hospital)
- Total costs of hospitalization(From the date of admission to the date of discharge, assessed up to 60 days.)
- User satisfaction with the system(From the date of inclusion of the first patient to the date of discharge of the last patient, assessed up to 12 months.)
研究者
Shengshou Hu
Professor
China National Center for Cardiovascular Diseases