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临床试验/NCT01324804
NCT01324804Unknown不适用

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

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2010年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
12
试验地点
1
主要终点
- Difference of tissue concentration of Teicoplanin between left and right pre-sternal subcutaneous tissue and between the subcutaneous tissue at the tight

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Written informed consent
  • Planned coronary artery bypass grafting with unilateral internal mammary artery bypass
  • Planned used of cardiopulmonary bypass

排除标准

  • Inability to give informed consent
  • Know allergy to cephalosporins, penicillin or Teicoplanin
  • Re-operation
  • Additional planned valve surgery
  • BMI > 30
  • Long standing diabetes mellitus (> 7 years)
  • Ejection fraction below 20% measured with transthoracic echocardiography
  • Chronic severe renal insufficiency
  • Childbearing potential

结局指标

主要结局

- Difference of tissue concentration of Teicoplanin between left and right pre-sternal subcutaneous tissue and between the subcutaneous tissue at the tight

时间窗: 10 hours

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

时间窗: 10 hours

measurement with microdialysis

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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