Concentration of cefazolin and linezolid in sternal tissue in coronary artery bypass grafting

Conditions: perioperative antibiotic prophylaxis during coronary artery bypass grafting
MedDRA version: 14.1Level: LLTClassification code 10036894Term: Prophylactic antibiotic therapySystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.1Level: PTClassification code 10011077Term: Coronary artery bypassSystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.1Level: PTClassification code 10064736Term: Antibiotic prophylaxisSystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.1Level: PTClassification code 10011078Term: Coronary artery diseaseSystem Organ Class: 10007541 - Cardiac disorders
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2011-005526-22-AT

Lead Sponsor: Medizinische Universität Wien

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

-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 <18 or >90
-Chronic severe liver or renal insufficiency
-Childbearing potential
-Drug or alcohol abuses
-Psychiatric disease
-Treatment with MAO – inhibiting or serotonergic medication