Clinical Trials Directory

Trials / Completed

CompletedNCT03141476

Adequacy of Perioperative Cefuroxime Dosage According to the BMI

Perioperative Cefuroxime in Obese Patients: Dosage According to the BMI

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Universitätsklinikum Hamburg-Eppendorf · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGCefuroxime 1,5gPatients with BMI of \<30kg/m\*m: 1,5 g Cefuroxime
DRUGCefuroxime 3gPatients with BMI of 30-50kg/m\*m: 3g Cefuroxime
DRUGCefuroxime 4,5gPatients with BMI of \>50kg/m\*m: 4,5 g Cefuroxime

Timeline

Start date
2017-03-01
Primary completion
2017-11-12
Completion
2017-12-12
First posted
2017-05-05
Last updated
2018-02-20

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT03141476. Inclusion in this directory is not an endorsement.