Adequacy of Perioperative Cefuroxime Dosage According to the BMI

Obesity; Drug Clinical Trial

Official title:

Perioperative Cefuroxime in Obese Patients: Dosage According to the BMI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03141476
• Other study ID #: AntibioticsCefuroximePV5153
• Status: Completed
• Phase: Phase 4
• First received: March 21, 2017
• Last updated: February 19, 2018
• Start date: March 1, 2017
• Est. completion date: December 12, 2017

Study information

• Verified date: February 2018
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 12, 2017
• Est. primary completion date: November 12, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity; Drug

Intervention

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

Locations

Country	Name	City	State
Germany	University Hospital Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum level of Cefuroxime	Drug Serum Level at skin cut	30-60 minutes after application of cefuroxime
Primary	Serum level of Cefuroxime	Drug Serum Level 45 minutes after skin cut	75-105 minutes after application of cefuroxime
Primary	Serum level of Cefuroxime	Drug Serum Level at the end of surgery	up to 150 minutes after application of cefuroxime
Primary	Tissue level of Cefuroxime	Drug Tissue Level at skin cut	30-60 minutes after application of cefuroxime
Primary	Tissue level of Cefuroxime	Drug Tissue Level 45 minutes after skin cut	75-105 minutes after application of cefuroxime
Primary	Tissue level of Cefuroxime	Drug Tissue Level at the end of surgery	up to 150 minutes after application of cefuroxime
Secondary	Surgical site infections	Incidence of surgical site infections	Time until hospital discharge, estimated time period: up to two weeks
Secondary	Hospital Retention period	Length of stay in hospital	Time until hospital discharge, estimated time period: 5-7 days