A Randomized, Prospective Study of Surgical Site Infections in Liver Transplant Patients Receiving Three Days of Peri-operative Antibiotic Prophylaxis Versus Intra-operative Antibiotics Only
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 102
- 主要终点
- Number of Subjects With Development of Surgical Site Infections
研究概览
简要总结
This study will be to prospectively determine differences in Surgical Site Infection (SSI) if a prolonged course of post-operative antibiotics are used following liver transplantation.
详细描述
This study will be to prospectively determine differences in SSI if a prolonged course of post-operative antibiotics are used following liver transplantation. All adult patients, admitted to the University of Virginia (UVA) Medical Center for first-time liver transplantation will be randomized to the standard of care of peri-operative antibiotics or extended course of three total days.
Patients will be evaluated primarily for the presence of post-operative surgical site infections but also for fever, elevated white blood counts, secondary infections (urinary tract, pneumonia, and blood stream), length of hospital stay, graft loss, and mortality for 30 days after liver transplant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •All patients ≥ 18 years of age.
- •Eligible for liver transplantation by UVA standard protocol.
- •First-time transplantation.
- •No active infections - requiring antibiotics - excluding antifungals.
排除标准
- •All patients < 18 years of age.
- •Previous liver transplantation.
- •Active infections - requiring antibiotics.
- •Allergy to all standard peri-operative antibiotics (piperacillin/tazobactam or UVA standard alternatives for Penicillin allergic patients: ciprofloxacin and vancomycin).
研究组 & 干预措施
standard peri-operative antibiotics
The standard of care at the University of Virginia Medical Center for liver transplantation patients is a 3.375 gram dose of piperacillin / tazobactam (Zosyn®) at the time of induction of anesthesia, though this dose may be adjusted for renal insufficiency. This dose is repeated during the operation every six hours.
干预措施: standard (Drug)
standard peri-operative antibiotics
The standard of care at the University of Virginia Medical Center for liver transplantation patients is a 3.375 gram dose of piperacillin / tazobactam (Zosyn®) at the time of induction of anesthesia, though this dose may be adjusted for renal insufficiency. This dose is repeated during the operation every six hours.
干预措施: liver transplant (Other)
extended three-day course of antibiotics
For those patients randomized to the study group, antibiotics will be started as per the usual intra-operative dosing regimen, then continued to provide coverage for 72 hours.
This is typically provided as additional doses of 3.375 grams of piperacillin / tazobactam (Zosyn®) every 8 hours for 3 total days (giving a total of 72 hours of antibiotic coverage), though this may be altered based on kidney function.
干预措施: extended (Drug)
extended three-day course of antibiotics
For those patients randomized to the study group, antibiotics will be started as per the usual intra-operative dosing regimen, then continued to provide coverage for 72 hours.
This is typically provided as additional doses of 3.375 grams of piperacillin / tazobactam (Zosyn®) every 8 hours for 3 total days (giving a total of 72 hours of antibiotic coverage), though this may be altered based on kidney function.
干预措施: liver transplant (Other)
结局指标
主要结局
Number of Subjects With Development of Surgical Site Infections
时间窗: within 30 days from surgery
development of surgical site infection, including superficial and deep incisional and organ space surgical site infections
次要结局
- Number of Subjects With Mortality(within 30 days from surgery)
- Number of Subjects With Post-operative Fever(24 hours from surgery)
- Number of Subjects With Elevated White Blood Count (WBC)(24 hours from surgery)
- Length of Hospital Stay(within 30 days from surgery)
- Number of Subjects With Nosocomial Infection(within 30 days from surgery)
- Number of Subjects With Graft Loss(within 30 days from surgery)
研究者
Robert Sawyer, MD
Profesor of Surgery
University of Virginia