Patients referred for CABG to the Department of Cardiac Surgery with planned isolated left mammary artery and vein/radial artery grafts preparation will be asked to participate in this trial.
Conditions
Interventions
Trade Name: Cefazolin 2g
Product Name: Cefazolin
Product Code: J01DB04
Pharmaceutical Form: Powder for solution for injection/infusion
INN or Proposed INN: Cefazolin
CAS Number: 25953-19-9
Current Spo
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Written informed consent. -Planned coronary artery bypass grafting with isolated left mammary artery bypass and vein grafts. -Planned use of cardiopulmonary bypass. 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 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: -Inability to give informed consent. -Know allergy to cephalosporin's, penicillin -Re-operation. -Preoperative renal failure. -Chronic severe renal insufficiency including haemodialysis. -BMI > 35. -Long standing diabetes mellitus (> 7 years) and insulin-dependent diabetes mellitus. -Ejection fraction <20% measured with transthoracic echocardiography. -Positive pregnancy test in patients with childbearing potential
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -To evaluate penetration in subcutaneous tissue levels of cefazolin continuously given and calculation of target attainment values compared to historical control (primary objective with regard to sample size calculation).;Secondary Objective: Not applicable ;Primary end point(s): To assess the potential beneficial effect with regard to target attainment at the side of potential post-surgical infection of an advanced preoperative antibiotic regime. Therefore, target attainment by a continuous infusion regimen of cefazolin (study group 1) will be compared to intermittent dosing (historical control performed by our study group). However, Cefazolin might not be effective in cased where prophylaxis against MRSA strains has to be performed, e.g. when the level of MRSA in the respective hospital is high or when the patient is already pre-colonized with MRSA. Therefore, we plan to test a novel antibiotic substance, namely Dalbavancin, and its tissue perfusion in CABG patients (study group 2). Dalbavancin is highly active against resistant gram-positive pathogens and has a half-life of 8 days, thereby intrinsically reflects the pharmacokinetic properties of continuous exposure which for antibiotic with short half-life has to be achieved by continuous infusion. Thereby we want to evaluate which strategy is best to overcome the perfusion deficit which impairs antibiotic tissue penetration to target tissue during CABG surgery and investigate if Dalbavancin is an alternative in case prophylaxis against MRSA has to be performed. ;Timepoint(s) of evaluation of this end point: End point would be evaluated after inclusion of 8 patients for Cefazolin group with exception that before subjects will be included in group. As in the historical group the safety purposes are evaluated right after inclusion the data of this arm will be compared to the historical group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable ;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Austria
Contacts
Public ContactCefazolin Martin Andreas
AKH Wien, Herzchirurgie Abteilung
Outcome results
None listed