Antibiotic Concentration in Internal Mammary Graft Preparation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01324804
First received: March 28, 2011
Last updated: NA
Last verified: December 2009
History: No changes posted

March 28, 2011
March 28, 2011
November 2010
Not Provided
  • - Difference of tissue concentration of Teicoplanin between left and right pre-sternal subcutaneous tissue and between the subcutaneous tissue at the tight [ Time Frame: 10 hours ] [ Designated as safety issue: No ]
    measurement with microdialysis
  • - Difference of tissue concentration of Cefazolin between left and right pre-sternal subcutaneous tissue and between the subcutaneous tissue at the tight [ Time Frame: 10 hours ] [ Designated as safety issue: No ]
    measurement with microdialysis
Same as current
No Changes Posted
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Antibiotic Concentration in Internal Mammary Graft Preparation
Target Tissue Concentration of Standard Antibiotic Treatment in Coronary Artery Bypass Grafting Using Left Internal Mammary Artery

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

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.

  • Coronary Heart Disease
  • Surgical Wound Infection
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CABG - subjects
only one group
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
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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
Both
18 Years and older
No
Contact: Martin Andreas, MD, MBA 00431404005262 martin.andreas@meduniwien.ac.at
Austria
 
NCT01324804
Version 1.1 - 19.11.2009
No
Medical University of Vienna, Department of Cardiothoracic- and Vascular Anaesthesia & Intensive Care Medicine
Medical University of Vienna
Not Provided
Not Provided
Medical University of Vienna
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP