Adequacy of Perioperative Cefuroxime Dosage According to the BMI

Universitätsklinikum Hamburg-Eppendorf

Status and phase: Completed; Phase 4

Conditions: Obesity; Drug

Treatments: Drug: Cefuroxime 1,5g; Drug: Cefuroxime 4,5g; Drug: Cefuroxime 3g

Study type: Interventional

Funder types: Other

Identifiers

NCT03141476

AntibioticsCefuroximePV5153

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Cefuroxime 1,5g

Other group

Description:

BMI \<30kg/m\*m

Treatment:

Drug: Cefuroxime 1,5g

Cefuroxime 3g

Other group

Description:

BMI 30-50kg/m\*m

Treatment:

Drug: Cefuroxime 3g

Cefuroxime 4,5g

Other group

Description:

BMI \>50kg/m\*m

Treatment:

Drug: Cefuroxime 4,5g