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Active Not RecruitingNCT07253805

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

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
70 (actual)
Sponsor
Laval University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2019-04-11
Primary completion
2022-02-16
Completion
2026-02-01
First posted
2025-11-28
Last updated
2025-11-28

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT07253805. Inclusion in this directory is not an endorsement.

Plasma and Tissue Concentration of Cefazolin in Preoperative Prophylaxis in Patients Undergoing Bariatric Surgery (NCT07253805) · Clinical Trials Directory