Comparison of a Morphomic-Based to the Standard-of-Care-Based Cefazolin Dose for Antimicrobial Prophylaxis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Proportion of Concentration Target Attainment
研究概览
简要总结
The goal of this clinical study is to compare the dosing of an antibiotic in overweight patients having surgery. The main question[s] it aims to answer are:
- Are the antibiotic concentrations in blood and fat tissue in patients that are overweight sufficient to prevent the chance of infection?
- Can dosing using body composition rather than body weight improve the chance of achieving good antibiotic concentrations in overweight patients? Participants will allow us to collect small amounts of blood and fat tissue during their regularly scheduled surgery.
Researchers will compare differences in antibiotic concentrations based on dosing by standard of care (body weight based) versus body composition.
详细描述
The risk of surgical site infections are higher in patients with obesity compared to non-obese adults. Our group has previously demonstrated that radiologic measures of abdominal subcutaneous fat are associated with surgical site infection risk in patients undergoing colorectal surgeries, which could reflect suboptimal antibiotic exposure in these patients. Therefore, we hypothesized that measures of abdominal size and composition in patients undergoing colorectal surgery would be more predictive of antimicrobial pharmacokinetics in this tissue compartment than the current standards of body weight and BMI. We confirmed this hypothesis and identified kidney function and body depth (by morphomics) to be predictive of cefazolin exposure in target tissue. Morphomics is a technology that transforms existing computed tomography data into body measures and composition. This study is a head-to-head comparison of this new proposed morphomic test regimen to the standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
This is open label
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
- •Accessible abdominal computed tomography scan prior to surgery
- •Adult patients > 18 years of age
- •Body Mass Index ≥ 25 kg/m^2
- •Expected to receive cefazolin prior to surgical incision
- •Estimated creatinine clearance ≥90 mL/min
排除标准
- •History of a hypersensitivity reaction to penicillin or cephalosporin
研究组 & 干预措施
Morphomic-based
The patients assigned to this group have cefazolin dose assignments based on body depth and kidney function.
干预措施: Cefazolin for Injection (Drug)
Standard of Care
The patients assigned to this group have cefazolin dose assignments based on body weight, which is the standard of care.
结局指标
主要结局
Proportion of Concentration Target Attainment
时间窗: 4 hours
Proportion of patients achieving at least 3.2 hours of time above 2 mcg/mL (MIC90) in subcutaneous fat tissue with the standard of care compared to morphomic-based dosing
次要结局
- Cefazolin exposure based on body depth(4 hours)
- Cefazolin exposure based on kidney function(4 hours)
研究者
Manjunath Prakash Pai
Professor
University of Michigan