Clinical trial NCT06005168: Comparison of a Morphomic-Based to the Standard-of-Care-Based Cefazolin Dose for Antimicrobial Prophylaxis
Official title: Comparison of a Morphomic-Based to the Standard-of-Care-Based Cefazolin Dose for Antimicrobial Prophylaxis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Surgical Prophylaxis
Keywords: Surgical Prophylaxis
Pharmacokinetics
Cefazolin
Obesity
Morphomics
Colorectal
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2023-08-22
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The current model for dosing the drug cefazolin includes the selection of 2 grams if the individual weighs less than 120 kg and 3 grams if they weigh 120 kg or more. The morphomic-based model defined the choice of 2 grams versus 3 grams of cefazolin based on kidney function and body depth.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Accessible abdominal computed tomography scan prior to surgery
2. Adult patients \> 18 years of age
3. Body Mass Index ≥ 25 kg/m\^2
4. Expected to receive cefazolin prior to surgical incision
5. Estimated creatinine clearance ≥90 mL/min

Exclusion Criteria:

1. History of a hypersensitivity reaction to penicillin or cephalosporin
2. Pregnancy

Primary outcomes:
measure: Proportion of Concentration Target Attainment
timeFrame: 4 hours
Secondary outcomes:
measure: Cefazolin exposure based on body depth
timeFrame: 4 hours
measure: Cefazolin exposure based on kidney function
timeFrame: 4 hours
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
References: