Adequacy of Perioperative Cefazolin for Surgery Antibiotic Prophylaxis in Obese Patients
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Assessment of the Pharmacokinetics of Cefazolin in the Morbidly Obese
研究概览
简要总结
The population continues to increase in weight. Currently there are no guidelines in the dosing of cefazolin for the obese population. Standard dosing of cefazolin 2 grams for patients <120 kg and 3 grams for patients >120 kg is used as the dose for surgical prophylaxis. This makes no provisions for weight based dosing. There has been some recent data which states this might not be enough for the obese patients. The primary objective of this study is to determine if weight based dosing (30 mg/kg) of cefazolin as surgical prophylaxis for patients undergoing elective gastric bypass/laparoscopic Roux-en-y gastric bypass provides appropriate serum concentrations for a larger percentage of time than the current method of giving the standard 2 or 3 gram doses of cefazolin peri-operatively. The concentration of cefazolin in tissue will also be measured to help assess this question.
详细描述
The hypothesis of this study is that customary doses of antibiotics, when administered for perioperative surgical prophylaxis, are insufficient to achieve adequate antibiotic concentrations in blood and tissues of morbidly obese patients (defined as a BMI greater than 40 kg/m2) and that these patients are therefore placed at high risk of surgical wound infections and poor clinical outcomes. Cefazolin is a first-generation cephalosporin commonly used for perioperative surgical prophylaxis in colorectal, abdominal, bariatric, gynecologic and obstetric, or orthopedic total joint arthroplasty surgical procedures. Previous cefazolin pharmacokinetic (PK) analysis in obese patients led to conflicting results and recommendations. It is not clearly know to what extent the pharmacokinetics of cefazolin in morbidly obese patients differ from those of non-obese patients. Specific dosing guidelines are then lacking. The main objective of this study is to assess the pharmacokinetics of cefazolin in morbidly obese after administrations of a standard recommended 2-3 g dose or a weight-base 30-mg/kg dose
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI greater than 40
- •No known history of allergy to cephalosporins
- •Scheduled for elective gastric bypass or laparoscopic Roux-en-y gastric bypass procedures
- •Able to read and understand English
排除标准
- •Patients <18 years of age or >89 Years of age
- •Pregnant women, prisoners and decisionally challenged subjects will be excluded
研究组 & 干预措施
Treatment group
Weight-based dose group (30 mg/kg cefazolin IV)
干预措施: Weight Based Group (Drug)
Control group
Standard dose group (2 g intravenous (IV) cefazolin dose for patients <120 kg, and 3 g IV cefazolin for patients >120 kg)
干预措施: Standard Dose Group (Drug)
结局指标
主要结局
Assessment of the Pharmacokinetics of Cefazolin in the Morbidly Obese
时间窗: Before cefazolin admin., then at 10, 30, 60, 120, 180 minutes after injection and at wound closure.
Since the goal of perioperative antimicrobial prophylaxis is to achieve free (unbound) serum and tissue drug levels that exceed the MIC for likely pathogens across the duration of the surgical procedure, and since redosing of cefazolin is recommended every 3-4 hours, PK/PD performance of cefazolin over that time frame will be analyzed. For the purposes of this study, pharmacodynamic targets are defined as fT\>MIC (time during which free drug concentrations exceed pathogen MICs) of 100% over periods of up to 4 hours in duration. The PK/PD probability of target attainment (PTA) for pharmacodynamic goals and the cumulative fraction of response (CFR) for both cefazolin regimens will be compared. A PTA of ≥90% and a CFR of ≥ 90% for a dosage regimen (i.e., predicted to meet pharmacodynamic targets in ≥ 90% of the total bacterial population across the full range of MICs) are considered optimum.
次要结局
- Hospital length of stay(Hospital discharge)
- Incidence of surgical site infection(Within 1 month postoperatively)
- Hospital readmission(Witihn 1 month after hospital discharge)
- Incidence of adverse outcomes(Within 1 month postoperatively)