effect of hypoalbuminemia on pharmacokinetics of cefazolin
Conditions
Interventions
Trade Name: Kefzol
Product Name: Kefzol (Cefazolin)
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: cefazolin
CAS Number: 25953-19-9
Other descriptive name: CEFAZOLIN SODIUM
Sponsors
Medical University of Vienna Department of Cardiac Thoracic Vascular Anesthesia and Intensive Care Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Written informed consent Planned use of cardiopulmonary bypass Age: > 18 and 40% 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 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: Inability to give informed consent Known allergy to penicillin/cephalosporins or cefazolin Preoperative antibiotic therapy Preoperative serum albumin concentration 35 Long standing diabetes mellitus (> 7 years) and insulin-dependent diabetes mellitus Pregnant women The standardized priming solution (1500ml Ringer’s Lactate, 100ml Mannit 20% and 10.000IE Heparin) is deemed inappropriate according to the treating physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective The area under the concentration-time curve from 0 - 10h (AUC0-10) for free and total drug will be compared between the control and intervention group. ;Secondary Objective: Secondary objectives The maximum (free + total) concentration of cefazolin over the dosing interval (Cmax), minimum (free + total) concentration of cefazolin over the dosing interval (Cmin), the duration of time that free drug concentrations remain above the MIC during the dosing interval (fT%>MIC), the ratio of AUC0-24 to MIC (AUC0-24/MIC), apparent volume of distribution (Vd) and plasma clearance (CL) and colloid osmotic pressure will be compared between the control and intervention group. ;Primary end point(s): AUC0-10 of cefazolin in treatment and control-group;Timepoint(s) of evaluation of this end point: after 10h | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Maximum concentration of cefazolin during the dosing intervals (Cmax) Minimum concentration of cefazolin during the dosing intervals (Cmin) Area under the concentration-time curve from 0 – 10h (AUC0-10) AUC 0-24 Duration of time that free drug concentrations remain above the MIC during a dosing interval in % (%fT>MIC) albumin und total protein levels colloid osmotic pressure (COP) ;Timepoint(s) of evaluation of this end point: for microdialysis and blood samples after (minutes) 0, 30, 60, 90, 120, 240, 360, 480, 600. for albumin/total protein and COP: preoperatively, after start of cardiopulmonary bypass, after termination of cardiopulmonary bypass | — |
Countries
Austria
Contacts
Public ContactDepartment of Cardiac Anesthesia
Medical University of Vienna
Outcome results
None listed