An open, randomized, single-center study assessing the serum time-concentration curves and the effect of prophylactic moxifloxacin (in comparison with cefuroxime) on the early inflammatory response to cardiopulmonary bypass in patients undergoing coronary artery bypass grafting - Moxi and CPB
- Conditions
- In this study prophylactic moxifloxacin 400 mg i.v. is compared with the above mentioned standard antibiotic prophylaxis cefuroxime regimen with special consideration to the postoperative inflammatory response. Additionally the serum time-concentration curves are evaluated for pharmacokinetic data and antimicrobial activity.
- Registration Number
- EUCTR2006-000369-12-DE
- Lead Sponsor
- Institute of Anaesthesiology, German Heart Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 30
coronary artery disease scheduled for coronary artery bypass grafting with 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
- Body mass index > 30
- Ejection fraction < 50 %
- Severe cardiac arrhythmias (long QT syndrome) or intake of drugs which prolong the QT interval (available from: http://www.torsades.org)
- Renal and hepatic dysfunction, evaluated by serum creatinine and SGOT/SGPT values above the normal range
- Intake of corticosteroids
- Allergies to quinolones, cephalosporins, aprotinin, or other drugs leading to the decision to omit these drugs or to give prophylactic antihistamines and corticosteroids
- Antibiotic therapy or infectious disease until 2 weeks before start of the trial
- Women who are pregnant (women with childbearing potential must have a negative pregnancy test) and nursing mothers
- Tendinopathies caused by quinolones
- Seizures
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the effect of prophylactic moxifloxacin and cefuroxime on the early inflammatory response to cardiopulmonary bypass in patients undergoing coronary artery bypass grafting;Secondary Objective: To assess the serum time-concentration curves for pharmacokinetic evaluation and antimicrobial activity in these patients;Primary end point(s): The difference between the moxifloxacin and cefuroxime group in the inflammatory response to cardiopulmonary bypass assessed by the level of pro- (IL6, IL8, TNFa) and anti-inflammatory (IL10) cytokines.
- Secondary Outcome Measures
Name Time Method