Target tissue concentration of standard antibiotic treatment in coronary artery bypass grafting using left internal mammary artery - Antibiotic concentration in internal mammary graft preparatio

Phase 1

Conditions: antibiotic target tissue protection during cardiac surgery with the use of an internal mammary artery graft to prevent deep sternal wound infection
MedDRA version: 12.0Level: LLTClassification code 10011078Term: Coronary artery disease
MedDRA version: 12.0Level: LLTClassification code 10036894Term: Prophylactic antibiotic therapy

Registration Number: EUCTR2009-016532-12-AT

Lead Sponsor: Medical University of Vienna

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

-Written informed consent
-Planned coronary artery bypass grafting with unilateral internal mammary artery bypass
-Planned used 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Inability to give informed consent
-Know allergy to cephalosporins, penicillin or Teicoplanin
-Re-operation
-Additional planned valve surgery
-Dialysis
-Chronic severe renal insufficiency
-Childbearing potential

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the impact of left internal mammary artery preparation on target tissue antibiotic concentration of Cefazolin and Teicoplanin during cardiac surgery;Secondary Objective: To evaluate the difference between subcutaneous persternal antibiotic concentration to concentration on the thigh;Primary end point(s): -Difference of tissue concentration of Teicoplanin between left and right pre-sternal subcutaneous tissue and between the subcutaneous tissue at the tight<br>-Difference of tissue concentration of Cefazolin between left and right pre-sternal subcutaneous tissue and between the subcutaneous tissue at the tight<br>-Pharmacokinetics in dual antibiotic prophylaxis<br>-Comparison of target tissue concentration to plasma concentration at different time points prior to, during and after cardiopulmonary bypass<br>

Secondary Outcome Measures