Antibiotic Concentration in Internal Mammary Graft Preparation

Coronary Heart Disease Clinical Trial

Official title:

Target Tissue Concentration of Standard Antibiotic Treatment in Coronary Artery Bypass Grafting Using Left Internal Mammary Artery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01324804
• Other study ID #: Version 1.1 - 19.11.2009
• Status: Recruiting
• Phase: N/A
• First received: March 28, 2011
• Last updated: March 28, 2011
• Start date: November 2010

Study information

• Verified date: December 2009
• Source: Medical University of Vienna
• Contact: Martin Andreas, MD, MBA
• Phone: 00431404005262
• Email: martin.andreas[@]meduniwien.ac.at
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Observational

Clinical Trial Summary

The negative effect of internal mammary harvesting on sternal perfusion is well known, especially in diabetic subjects. Microdialysis previously showed increased lactate tissue concentration after mammary artery preparation. Although high antibiotic concentration is of utmost importance in this region, no study previously measured the effect of internal mammary artery harvesting on target tissue antibiotic concentration.

Study hypothesis:

Internal mammary artery harvesting imposes an additional risk for deep sternal wound infection by impairing antibiotic tissue penetration. This effect is mediated by altered perfusion patterns and may be seen in cephalosporin and/or Teicoplanin treatment.

Study objective:

To evaluate the impact of left internal mammary artery preparation on target tissue antibiotic concentration of Cefazolin and Teicoplanin during cardiac surgery

Design:

This study is designed as an observational pharmacokinetic trial. Patients are their own controls by measuring antibiotic concentration in different subcutaneous tissues.

Study population:

Patients referred for coronary artery bypass grafting to the Department of Cardiothoracic Surgery with planned unilateral left internal mammary artery preparation and a high risk profile for deep sternal wound infections will be asked to participate in this trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written informed consent

• Planned coronary artery bypass grafting with unilateral internal mammary artery bypass

• Planned used of cardiopulmonary bypass

Exclusion Criteria:

• Inability to give informed consent

• Know allergy to cephalosporins, penicillin or Teicoplanin

• Re-operation

• Additional planned valve surgery

• Dialysis

• BMI > 30

• Long standing diabetes mellitus (> 7 years)

• Ejection fraction below 20% measured with transthoracic echocardiography

• Chronic severe renal insufficiency

• Childbearing potential

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Myocardial Ischemia
• Surgical Wound Infection
• Wound Infection

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- Difference of tissue concentration of Teicoplanin between left and right pre-sternal subcutaneous tissue and between the subcutaneous tissue at the tight	measurement with microdialysis	10 hours	No
Primary	- Difference of tissue concentration of Cefazolin between left and right pre-sternal subcutaneous tissue and between the subcutaneous tissue at the tight	measurement with microdialysis	10 hours	No