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.
Conditions
Interventions
Trade Name: Human Albumin "CSL Behring" 20% Infusionslösung
Product Name: Human Albumin “CSL Behring” 20% Infusionslösung
Product Code: 908884214165
Pharmaceutical Form: Infusion
INN or Proposed INN:
Sponsors
Department of Cardiothoracic Anesthesia and Intensive Care Medicine, Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: • 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 2 mg/L and/or GFR 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)
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Volume distribution (Vd) Total proteins Albumin concnetration ICU Stay Hospital Stay Time to extubation Rate of postoperative infections;Timepoint(s) of evaluation of this end point: on study days, for the whole duration of the study including follow-up of adverse events if necessary. | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Hypoalbuminemia is a common feature in patients undergoing cardiac surgery due to the initial volume load provided by the heart lung machine. The use of crystalloid priming was shown to be safe in coronary artery bypass grafting surgery in adults. However, there is some debate on the impact of low plasma colloid pressure, especially hypoalbuminemia and the changes in pharmacokinetics of plasma protein bound antibiotics. Hypoalbuminemia leads to an increased clearance and therefore a decreased AUC of the effective unbound form of plasma protein bound antibiotics. In this study, we want to investigate the pharmacokinetic effects of Cefazolin comparing patients with normal and patients with reduced albumin levels during cardiac surgery.;Secondary Objective: We further want to evaluate if the substitution of the cardiopulmonary bypass priming with albumin has an effect on ICU stay, hospital, stay, time to extubation and rate of postoperative infections.;Primary end point(s): Area under the concentration time curve (AUC) Max.Concentration (Cmax) Clearance (CL);Timepoint(s) of evaluation of this end point: After administration of albumin (single dose) on the study day. | — |
Countries
Austria
Contacts
Public ContactOffice
Cardiothoracic Anesth & Intensive Care Med, MUV
Outcome results
None listed