Adequacy of Perioperative Cefuroxime Dosage According to the BMI

Study Overview
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Brief Summary
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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
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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.

Official Title
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Perioperative Cefuroxime in Obese Patients: Dosage According to the BMI

Conditions
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Obesity; Drug

Intervention / Treatment
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* Drug: Cefuroxime 1,5g
* Drug: Cefuroxime 3g
* Drug: Cefuroxime 4,5g


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: BMI: <30kg/m*m: 1,5g, 31-50kg/m*m: 3,0g, >50kg/m*m: 4,5g
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cefuroxime 1,5g<br>BMI <30kg/m*m | Drug: Cefuroxime 1,5g<br>* Patients with BMI of <30kg/m*m: 1,5 g Cefuroxime<br>|
| Other: Cefuroxime 3g<br>BMI 30-50kg/m*m | Drug: Cefuroxime 3g<br>* Patients with BMI of 30-50kg/m*m: 3g Cefuroxime<br>|
| Other: Cefuroxime 4,5g<br>BMI >50kg/m*m | Drug: Cefuroxime 4,5g<br>* Patients with BMI of >50kg/m*m: 4,5 g Cefuroxime<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum level of Cefuroxime | Drug Serum Level at skin cut | 30-60 minutes after application of cefuroxime | 
| Serum level of Cefuroxime | Drug Serum Level 45 minutes after skin cut | 75-105 minutes after application of cefuroxime | 
| Serum level of Cefuroxime | Drug Serum Level at the end of surgery | up to 150 minutes after application of cefuroxime | 
| Tissue level of Cefuroxime | Drug Tissue Level at skin cut | 30-60 minutes after application of cefuroxime | 
| Tissue level of Cefuroxime | Drug Tissue Level 45 minutes after skin cut | 75-105 minutes after application of cefuroxime | 
| Tissue level of Cefuroxime | Drug Tissue Level at the end of surgery | up to 150 minutes after application of cefuroxime | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery, Obesity, Drug, Antibiotics, Cefuroxime