University of Michigan Hospital
Ann Arbor, Michigan, 48108, United States
NCT Number: NCT06005168
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Ann Arbor, Michigan, 48108, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2 grams or 3 grams based on standard of care or morphomic-based decision
Time frame: 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
Time frame: 4 hours
Compare the area under the curve from time 0 to 4 hours (AUC0-4) in plasma and subcutaneous fat in patients with a body depth above and below 350 mm
Time frame: 4 hours
Compare the area under the curve from time 0 to 4 hours (AUC0-4) in plasma and subcutaneous fat in patients with an estimated creatinine clearance above and below 120 mL/min
University of Michigan
Other
Acronym: MorphAbxPKSurg
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