Peri- and postoperative subcutaneous adipose tissue cefazolin determination using microdialysis in morbidly obese and non-obese patients
Completed
- Conditions
- Obesitasprevention of wound infection in obese patientswound infection after surgery in obese patients10017998
- Registration Number
- NL-OMON36673
- Lead Sponsor
- Sint Antonius Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
Inclusion Criteria
8 morbidly obese patients Body Mass Index > 40 kg/m2 undergoing bariatric surgery, 21-60 years old. We will stratify subjects to 4 weight groups: 100-125 kg; 125-150 kg; 150-180 kg; >180 kg.
8 non-obese adults (BMI >19<30; age 21-60 years) undergoing surgery which includes cefazolin and nadroparin administration perioperatively and a postoperative stay at the post anesthesia care unit (PACU).
Exclusion Criteria
Pregnancy, breastfeeding, known allergy for cefazolin/nadroparin, known ejection fraction of <35%, renal insufficiency, hematochromatosis.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoints:<br /><br>1. Cefazolin concentrations in subcutaneous adipose tissue<br /><br>2. Total and unbound cefazolin concentration in plasma<br /><br>3. Cefazolin unbound subcutaneous tissue/unbound plasma concentration ratio<br /><br>differences between morbidly obese and non-obese patients</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints:<br /><br>1. Anti-factor Xa concentrations: 11 samples in non-obese patients, 3 in<br /><br>morbidly obese patients) in blood following nadroparin<br /><br>Tertiary endpoints:<br /><br>1. Pharmacokinetic parameters of cefazolin<br /><br>2. Pharmacodynamic parameters of nadroparin<br /><br>3. The occurrence of postoperative SSI<br /><br>4. The occurrence of deep vein thrombosis /pulmonary embolism</p><br>