Adequacy of Perioperative Cefuroxime Dosage According to the BMI

Perioperative Cefuroxime in Obese Patients: Dosage According to the BMI

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Drug
• Intervention / Treatment: Drug: Cefuroxime 1,5g; Drug: Cefuroxime 3g; Drug: Cefuroxime 4,5g

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • University Hospital Hamburg-Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cefuroxime 1,5g; BMI <30kg/m*m	Drug: Cefuroxime 1,5g; Patients with BMI of <30kg/m*m: 1,5 g Cefuroxime
Other: Cefuroxime 3g; BMI 30-50kg/m*m	Drug: Cefuroxime 3g; Patients with BMI of 30-50kg/m*m: 3g Cefuroxime
Other: Cefuroxime 4,5g; BMI >50kg/m*m	Drug: Cefuroxime 4,5g; Patients with BMI of >50kg/m*m: 4,5 g Cefuroxime

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): November 12, 2017
• Study Completion (Actual): December 12, 2017

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (Actual): May 5, 2017

Study Record Updates

• Last Update Posted (Actual): February 20, 2018
• Last Update Submitted That Met QC Criteria: February 19, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Obesity; Surgery; Antibiotics; Drug; Cefuroxime
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Anti-Infective Agents; Anti-Bacterial Agents; Cefuroxime; Cefuroxime axetil
• Other Study ID Numbers: AntibioticsCefuroximePV5153

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No