Prevention of Infections in Cardiac Surgery (PICS): a Cluster-randomized Factorial Cross-over Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 38,000
- 主要终点
- Deep incisional or organ/space (complex) sternal surgical site infection (CDC/NHSN)
研究概览
简要总结
The goal of this pragmatic, multi-centre factorial cluster randomized cross-over trial is to assess the efficacy of a combination of cefazolin plus vancomycin compared to cefazolin monotherapy, as well as a comparison of short versus long-term prophylaxis with four study arms: 1) cefazolin short-term, 2) cefazolin long-term, 3) cefazolin plus vancomycin short-term and 4) cefazolin plus vancomycin long-term.
详细描述
Although antibiotic prophylaxis is considered the cornerstone of prevention for sternal surgical site infections (s-SSIs), the most effective antimicrobial regimen and optimal duration remain unclear. There is a pressing need to determine how best to prevent sternal surgical site infections and at the same time reduce adverse events from unnecessary antibiotic exposure. Currently, due to the lack of evidence, unproven approaches prevail and adherence to guidelines is poor. Rigorous randomized controlled trials data are needed for improved patient care.
A factorial cluster randomized cross-over trial, a design not used previously in this field, will address these gaps. To date, we have successfully enrolled close to 6,000 eligible patients in the vanguard study, and have shown that the trial as planned is feasible and operationally highly cost-effective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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 patients (≥18 years of age) undergoing open-heart surgery (i.e. sternotomy, including minimally-invasive surgical techniques through mini-sternotomies)
排除标准
- •On systemic antibiotics or with an active bacterial infection at the time of surgery
- •Previously enrolled in this trial
- •Known to be colonized with methicillin-resistant staphylococcus aureus (MRSA). Where it is unethical to not administer glycopeptides.
- •Beta-lactam or vancomycin allergy precluding the use of cefazolin or vancomycin, respectively
- •Participation in other studies that may interfere with this trial.
- •Patients undergoing cardiac transplant
研究组 & 干预措施
cefazolin short-term
Cefazolin 2g (or 3g if greater than 120kg body weight) will be given within an hour of surgery. The intraoperative dose at 4 hours after the first dose or upon wound closure (whatever comes first).
干预措施: Cefazolin (Drug)
cefazolin long-term
Cefazolin 2g (or 3g if greater than 120kg body weight) will be given within an hour of surgery. The intraoperative dose at 4 hours after the first dose or upon wound closure (whatever comes first) and the five post-operative doses in the long-term arms will be 2g every 8 hours.
干预措施: Cefazolin (Drug)
cefazolin plus vancomycin short-term
Cefazolin 2g (or 3g if greater than 120kg body weight) will be given within an hour of surgery. The intraoperative dose at 4 hours after the first dose or upon wound closure (whatever comes first). Vancomycin will be dosed at roughly 15mg/kg body weight intravenously, i.e. 1g or 1.5g if greater than 85kg body weight and is to be administered within 60-90 minutes of the surgical procedure.
干预措施: Cefazolin (Drug)
cefazolin plus vancomycin short-term
Cefazolin 2g (or 3g if greater than 120kg body weight) will be given within an hour of surgery. The intraoperative dose at 4 hours after the first dose or upon wound closure (whatever comes first). Vancomycin will be dosed at roughly 15mg/kg body weight intravenously, i.e. 1g or 1.5g if greater than 85kg body weight and is to be administered within 60-90 minutes of the surgical procedure.
干预措施: Vancomycin (Drug)
cefazolin plus vancomycin long-term
Cefazolin 2g (or 3g if greater than 120kg body weight) will be given within an hour of surgery. The intraoperative dose at 4 hours after the first dose or upon wound closure (whatever comes first) and the five post-operative doses in the long-term arms will be 2g every 8 hours. Vancomycin will be dosed at roughly 15mg/kg body weight intravenously, i.e. 1g or 1.5g if greater than 85kg body weight and is to be administered within 60-90 minutes of the surgical procedure. The same dose will be used for the 3 post-operative doses in the long-term arm.
干预措施: Cefazolin (Drug)
cefazolin plus vancomycin long-term
Cefazolin 2g (or 3g if greater than 120kg body weight) will be given within an hour of surgery. The intraoperative dose at 4 hours after the first dose or upon wound closure (whatever comes first) and the five post-operative doses in the long-term arms will be 2g every 8 hours. Vancomycin will be dosed at roughly 15mg/kg body weight intravenously, i.e. 1g or 1.5g if greater than 85kg body weight and is to be administered within 60-90 minutes of the surgical procedure. The same dose will be used for the 3 post-operative doses in the long-term arm.
干预措施: Vancomycin (Drug)
结局指标
主要结局
Deep incisional or organ/space (complex) sternal surgical site infection (CDC/NHSN)
时间窗: 3 months post-surgery
Sternal surgical site infections are defined by clinical and microbiological criteria of infection at the surgical site that are associated with the operative procedure occurring within 90 days after surgery.
次要结局
- Clostridium difficile infection(3 months post-surgery)
- All types of sternal surgical site infections (superficial, deep, organ; (CDC/NHSN)(3 months post-surgery)
- Mortality(3 months post-surgery)
- Number of patients with acute kidney injury(7 days post surgery)
- Number of patients with sternal revision surgery(3 months post surgery)
- Rate of antimicrobial resistant organisms causing sternal wound infections(3 months post-surgery)