跳至主要内容
临床试验/NCT07253805
NCT07253805进行中(未招募)不适用

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

Laval University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年4月11日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
70
试验地点
1
主要终点
Area Under the Concentration-Time Curve (AUC) of Cefazolin in Plasma, Adipose Tissue, and Dermal Tissue

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Have a BMI ≥ 35 kg/m²
  • •Undergo bariatric surgery (sleeve gastrectomy) via laparoscopy

排除标准

  • •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

结局指标

主要结局

Area Under the Concentration-Time Curve (AUC) of Cefazolin in Plasma, Adipose Tissue, and Dermal Tissue

时间窗: 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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

François Julien

General and Bariatric Surgeon, and Clinical Researcher, MD.

Laval University

研究点 (1)

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