What are the optimal doses of cephalosporins of first and second generation to manage obese patients?
Phase 1
- Conditions
- Antibiotic prophylaxis in digestive surgery or any other surgery with antibiotic prophylaxisMedDRA version: 14.1Level: PTClassification code 10036898Term: ProphylaxisSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2011-004070-29-BE
- Lead Sponsor
- Hopital Erasme
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
-patient age >= 18y with BMI >= 15 kg/m²
-who has a bariatric (gastric BYPASS) or a digestive surgery or any other surgery
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
Exclusion Criteria
-Patient treated with different dose of cefuroxim or cefazolin
-pregnant woman
-unscheduled surgery
-patient unable to give consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the optimal doses of first and second generation cephalosporins in obese patients by comparing the results from the obese patient group to the results from the non-obese patient group (case-control)<br>;Secondary Objective: To best evaluate the renal function, a dosage of Cystatin C will be performed;Primary end point(s): NA;Timepoint(s) of evaluation of this end point: NA
- Secondary Outcome Measures
Name Time Method Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA