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Clinical Trials/NCT07253805
NCT07253805Active, not recruitingNot Applicable

Plasma and Tissue Concentration of Cefazolin in Preoperative Prophylaxis in Patients Undergoing Bariatric Surgery

Laval University1 site in 1 country70 target enrollmentStarted: April 11, 2019Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

François Julien

General and Bariatric Surgeon, and Clinical Researcher, MD.

Laval University

Study Sites (1)

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