Adequacy of Perioperative Cefuroxime Dosage According to the BMI

Phase 4

Completed

• Conditions: Obesity; Drug
• Interventions: Drug: Cefuroxime 3g; Drug: Cefuroxime 1,5g; Drug: Cefuroxime 4,5g

• Registration Number: NCT03141476
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

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.

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 Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-03-21
• Study First Submitted QC: 2017-05-02
• Study First Posted: 2017-05-05
• Primary Completion: 2017-11-12
• Study Completion: 2017-12-12
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-19
• Last Update Posted: 2018-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cefuroxime 3g	Cefuroxime 3g	BMI 30-50kg/m\*m
Cefuroxime 1,5g	Cefuroxime 1,5g	BMI \<30kg/m\*m
Cefuroxime 4,5g	Cefuroxime 4,5g	BMI \>50kg/m\*m

Primary Outcome Measures

Name	Time	Method
Serum level of Cefuroxime	up to 150 minutes after application of cefuroxime	Drug Serum Level at the end of surgery
Tissue level of Cefuroxime	up to 150 minutes after application of cefuroxime	Drug Tissue Level at the end of surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany