A Phase 4 interventional study of Cefuroxime 1,5g and Cefuroxime 3g in Obesity; Drug, sponsored by Universitätsklinikum Hamburg-Eppendorf. Completed at 1 site in Germany. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-20.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Phase 4, Interventional, and Prevention
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.
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.
6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.
This study's enrollment of 60 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 403 studies on the registry; 83 are open to participants now.
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Exclusion Criteria:
BMI \<30kg/m\*m
Drug: Cefuroxime 1,5g
BMI 30-50kg/m\*m
Drug: Cefuroxime 3g
BMI \>50kg/m\*m
Drug: Cefuroxime 4,5g
Patients with BMI of \<30kg/m\*m: 1,5 g Cefuroxime
Patients with BMI of 30-50kg/m\*m: 3g Cefuroxime
Patients with BMI of \>50kg/m\*m: 4,5 g Cefuroxime
Serum level of Cefuroxime
Drug Serum Level at skin cut
Time frame: 30-60 minutes after application of cefuroxime
Serum level of Cefuroxime
Drug Serum Level 45 minutes after skin cut
Time frame: 75-105 minutes after application of cefuroxime
Serum level of Cefuroxime
Drug Serum Level at the end of surgery
Time frame: up to 150 minutes after application of cefuroxime
Tissue level of Cefuroxime
Drug Tissue Level at skin cut
Time frame: 30-60 minutes after application of cefuroxime
Tissue level of Cefuroxime
Drug Tissue Level 45 minutes after skin cut
Time frame: 75-105 minutes after application of cefuroxime
Tissue level of Cefuroxime
Drug Tissue Level at the end of surgery
Time frame: up to 150 minutes after application of cefuroxime
Surgical site infections
Incidence of surgical site infections
Time frame: Time until hospital discharge, estimated time period: up to two weeks
Hospital Retention period
Length of stay in hospital
Time frame: Time until hospital discharge, estimated time period: 5-7 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Universitätsklinikum Hamburg-Eppendorf