Plasma pharmakocinetics of prophylactic Cefazolin administration for cardiac surgery: comparison of cardiopulmonary bypass priming with additive human Albumin 20% vs pure crystalloid priming
- Conditions
- This is a pharmacokinetic trial for patients undergoing cardiac surgery. It will be investigated whether cardiopulmonary bypass priming substituted with human albumin 20% has an effect on the pharmacokinetics of prophylactic Cefazolin versus standard priming. The information retrieved by these investigations will help to optimize antiinfective treatment in patients undergoing cardiac surgery.Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2020-002756-21-AT
- Lead Sponsor
- Department of Cardiothoracic Anesthesia and Intensive Care Medicine, Medical University of Vienna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 40
•Written informed consent
•Patients undergoing elective aortic valve repair
•Patients undergoing elective mitral valve repair
•Patients undergoing elective coronary artery bypass grafting
•Age: 18 – 85 years of age
•BMI: 20 -35 kg/m2
•No former allergic reaction to albumin
•No former allergic reaction to cefazolin
•Ejection fraction > 25%
•No former cardiac surgery
•Hemoglobin concentration > 11 mg/dL prior to surgery
•Serum creatinin < 2 mg/dL
•No significant hepatic disease (liver function tests < 3 X upper limit of normal)
•No history of coagulation disorders
•No signs of local or systemic infection
•No antibiotic therapy within the last 3 days
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
•No informed consent
•Emergency cardiac surgery
•History of hypersensitivity to ß-lactam antibiotics
•History of allergic reaction to albumin
•Infection at site of surgery
•Systemic infection (endocarditis)
•Antimicrobial therapy within 3 days of surgery
•Former cardiac surgery
•Hemoglobin concentration < 11 mg/dL prior to surgery
•Congestive heart failure with ejection fraction < 25%
•Significant hepatic disease (liver function tests < 3 X upper limit of normal)
•Renal impairment with serum creatinine > 2 mg/L and/or GFR <60mL/min
•Body Mass Index (BMI) < 20 kg/m2 or BMI > 35 kg/m2
• Pregnancy or missing pregnancy test
• Perioperative need of Levosimendan (will lead to drop out)
• Aortic clamping time >240 minutes (will lead to drop out)
• Extra corporal circuit time >400 minutes (will lead to drop out)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method