Adequacy of Perioperative Cefuroxime Dosage According to the BMI

Overview

This study evaluates the dosage of perioperative cefuroxime for obese patients. Dosage was increased if the BMI was over 30kg/m*m and as well over 50kg/m*m. Drug levels were measured in blood and tissue.

Full Title of Study: “Perioperative Cefuroxime in Obese Patients: Dosage According to the BMI”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 12, 2017

Detailed Description

Cefuroxime is an often used antibiotic for surgery antibiotic prophylaxis to avoid surgical wound infection. In this study the dosage of cefuroxime was adjusted to the BMI:

less than 30kg/m*m: 1,5g 31-50kg/m*m: 3,0g more than 50kg/m*m: 4,5g

Cefuroxime was applicated 30 to 60 minutes before the begin of surgery. Drug Levels in blood and fat tissue were measured at skin cut (30-60 minutes after application of Cefuroxime), 45 minutes after skin cut (75-105 minutes after minutes after application of Cefuroxime) and at the end of surgery (up to 150 minutes after application of Cefuroxime) .

The hypothesis of this study is that adequate drug levels are reached in all groups.

Interventions

  • Drug: Cefuroxime 1,5g
    • Patients with BMI of <30kg/m*m: 1,5 g Cefuroxime
  • Drug: Cefuroxime 3g
    • Patients with BMI of 30-50kg/m*m: 3g Cefuroxime
  • Drug: Cefuroxime 4,5g
    • Patients with BMI of >50kg/m*m: 4,5 g Cefuroxime

Arms, Groups and Cohorts

  • Other: Cefuroxime 1,5g
    • BMI <30kg/m*m
  • Other: Cefuroxime 3g
    • BMI 30-50kg/m*m
  • Other: Cefuroxime 4,5g
    • BMI >50kg/m*m

Clinical Trial Outcome Measures

Primary Measures

  • Serum level of Cefuroxime
    • Time Frame: 30-60 minutes after application of cefuroxime
    • Drug Serum Level at skin cut
  • Serum level of Cefuroxime
    • Time Frame: 75-105 minutes after application of cefuroxime
    • Drug Serum Level 45 minutes after skin cut
  • Serum level of Cefuroxime
    • Time Frame: up to 150 minutes after application of cefuroxime
    • Drug Serum Level at the end of surgery
  • Tissue level of Cefuroxime
    • Time Frame: 30-60 minutes after application of cefuroxime
    • Drug Tissue Level at skin cut
  • Tissue level of Cefuroxime
    • Time Frame: 75-105 minutes after application of cefuroxime
    • Drug Tissue Level 45 minutes after skin cut
  • Tissue level of Cefuroxime
    • Time Frame: up to 150 minutes after application of cefuroxime
    • Drug Tissue Level at the end of surgery

Secondary Measures

  • Surgical site infections
    • Time Frame: Time until hospital discharge, estimated time period: up to two weeks
    • Incidence of surgical site infections
  • Hospital Retention period
    • Time Frame: Time until hospital discharge, estimated time period: 5-7 days
    • Length of stay in hospital

Participating in This Clinical Trial

Inclusion Criteria

  • elective laparoscopic Intervention
  • BMI < 90 kg/m*m
  • age: 18-85 years

Exclusion Criteria

  • known history of allergy to cefuroxime or other cephalosporines
  • absent consent skill
  • elective open surgery
  • preoperative therapy with antibiotics
  • patient's denial of the study

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Universitätsklinikum Hamburg-Eppendorf
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. med. Jakob Mueller, Senior Physician – Universitätsklinikum Hamburg-Eppendorf

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