perioperative antibiotic prophylaxis during coronary artery bypass grafting MedDRA version: 14.1 Level: LLT Classification code 10036894 Term: Prophylactic antibiotic therapy System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: PT Classification code 10011077 Term: Coronary artery bypass System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: PT Classification code 10064736 Term: Antibiotic prophylaxis System Organ Class
Conditions
Interventions
Trade Name: CEFAZOLIN "Sandoz" 2g - Trockenstechampulle
Product Name: CEFAZOLIN "Sandoz" 2g - Trockenstechampulle
Pharmaceutical Form: Infusion
INN or Proposed INN: CEFAZOLIN SODIUM
CAS Number: 27164-
Sponsors
Medizinische Universität Wien
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Written informed consent - Planned coronary artery bypass grafting - Planned used of cardiopulmonary bypass - Age = 18 and = 90 years - No pre-existing liver or kidney disease - Left ventricular ejection fraction > 40% - No pre-existing osteoporosis requiring therapy 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - Preoperative antibiotic treatment - Preoperative signs of infection - Inability to give informed consent or missing informed consent - Know allergy to cephalosporins, penicillin or Linezolid - Re-operation - Additional planned valve surgery - Preoperative renal replacement therapy - BMI > 40 - Long standing diabetes mellitus (> 7 years) - Preoperative osteoporosis requiring therapy - Age 90 - Chronic severe liver or renal insufficiency - Childbearing potential - Drug or alcohol abuses - Psychiatric disease - Treatment with MAO – inhibiting or serotonergic medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -To evaluate the target tissue concentration of cefazolin and linezold in sternal bone marrow of patients undergoing coronary artery bypass grafting -To assess the impact of left internal mammary artery preparation on target tissue antibiotic concentration in sternal spongiosa ;Secondary Objective: -Pharmacokinetics in dual antibiotic prophylaxis;Primary end point(s): -Perioperative time to concentration profiles of cefazolin and linezolid in plasma and additionally in sternal spongiosa -Difference of tissue concentration of linezolid between left and right sternal spongiosa tissue -Difference of tissue concentration of cefazolin between left and right sternal spongiosa tissue -Difference of antibiotic penetration (cefazolin versus linezolid);Timepoint(s) of evaluation of this end point: Cefazolin and Linezolid plasma levels will be drawn at baseline and at 30, 60, 90, 120, 150, 180 min after drug administration followed by blood draws every two hours thereafter for 24 hours. Then again at 720, 750, 780, 810, 840 hours after the first administration and then every two hours until 1440 mins after the first administration (see time schedule in protocol) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Pharmacokinetics in dual antibiotic prophylaxis;Timepoint(s) of evaluation of this end point: Cefazolin and Linezolid plasma levels will be drawn at baseline and at 30, 60, 90, 120, 150, 180 min after drug administration followed by blood draws every two hours thereafter for 24 hours. Then again at 720, 750, 780, 810, 840 hours after the first administration and then every two hours until 1440 mins after the first administration (see time schedule in protocol) | — |
Countries
Austria
Contacts
Public ContactDepartment of Cardiac Anaesthesia
Medical University of Vienna
Outcome results
None listed