Plasma and Tissue Concentration of Cefazolin in Preoperative Prophylaxis in Patients Undergoing Bariatric Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Laval University
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Area Under the Concentration-Time Curve (AUC) of Cefazolin in Plasma, Adipose Tissue, and Dermal Tissue
Study Overview
Brief Summary
This study investigates whether current cefazolin dosing guidelines for obese patients-2 g IV for those <120 kg and 3 g IV for those ≥120 kg-achieve adequate plasma and tissue concentrations (≥8 mg/L) for effective surgical prophylaxis. While several retrospective and prospective studies suggest that a 2 g dose may be sufficient regardless of weight, findings are inconsistent and often rely solely on plasma concentrations. Given that tissue concentration at the site of action is a more relevant pharmacokinetic marker, the study emphasizes the need to measure cefazolin levels in adipose tissue. Previous research using microdialysis has shown reduced tissue distribution in obese patients, potentially warranting higher doses. The study also highlights variability in defining the minimum inhibitory concentration (MIC) required for prophylaxis, noting that 8 mg/L is often considered the threshold for Enterobacteriaceae. Ultimately, the study aims to clarify whether current dosing achieves effective antibiotic levels across different weight categories, with a focus on tissue concentrations.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Have a BMI ≥ 35 kg/m²
- •Undergo bariatric surgery (sleeve gastrectomy) via laparoscopy
Exclusion Criteria
- •Under 18 years of age
- •Weight over 180 kg
- •Penicillin allergy
- •Pregnant or breastfeeding women
- •Chronic kidney disease (eGFR < 60 ml/min according to the Cockcroft-Gault equation)
- •Liver cirrhosis
- •Intraoperative blood loss ≥ 1 liter
Outcomes
Primary Outcomes
Area Under the Concentration-Time Curve (AUC) of Cefazolin in Plasma, Adipose Tissue, and Dermal Tissue
Time Frame: During surgery
AUC of cefazolin will be measured in plasma, adipose tissue, and dermal tissue at 0 minutes, 30 minutes, and at the end of surgery following administration according to current dosing guidelines. Unit of Measure: mg·min/L
Secondary Outcomes
- Proportion of Patients Achieving Cefazolin Tissue Concentrations ≥ 8 mg/L(During surgery)
- Proportion of Patients Achieving Cefazolin Plasma Concentrations ≥ 2 mg/L(During surgery)
- Comparison of Cefazolin Concentrations Across Weight Categories(During surgery)
- Tissue-to-Plasma Concentration Ratio of Cefazolin(During surgery)
- Time Above MIC (T>MIC) for Cefazolin in Plasma and Tissue(During surgery)
Investigators
François Julien
General and Bariatric Surgeon, and Clinical Researcher, MD.
Laval University
