Influence of extracorporeal circulation on perioperative cefuroxime concentrations in bypass surgery patients.Exploratory, prospective, open-label, monocentric study to investigate the influence of operative extracorporeal circulation on perioperative cefuroxime concentrations using microdialysis technique in bypass surgery patients

Not Applicable

Recruiting

Conditions: I25
T98
Chronic ischaemic heart disease
Sequelae of other and unspecified effects of external causes

Registration Number: DRKS00030889

Lead Sponsor: niversitätsklinikum Augsburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Patients undergoing elective bypass surgery who require perioperative antibiotic prophylaxis
- Written declaration of consent by the patient

Exclusion Criteria

- Patients who have received therapy with cefuroxime in the 72 hours prior to surgery.
- Known allergic reaction, hypersensitivity or contraindication to cefuroxime or other ß-lactam antibiotics (e.g. penicillins, cephalosporins).
- Severe renal insufficiency < 20 ml/min/1.73 m2
- Non-guideline discontinuation of blood thinning medications
Medications if urgency does not allow the surgery to be postponed for the appropriate number of days.
- Active participation in other interventional studies according to AMG or MPDG
- Women during pregnancy or breastfeeding

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The area under the concentration-time curve (AUC 0-8) of cefuroxime in interstitial fluid and plasma

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters: <br>- Area under the concentration-time curve (AUC).<br>- maximum concentrations (Cmax), <br>- Cmax/MIC (MIC = minimal inhibitory concentration)<br>- AUC/MIC in interstitial fluid and plasma after drug application, <br>- time over MIC (T>MIC)<br>- AUCtissue/AUCplasma ratio, <br>- PK/PD parameters, <br>- half-lives (t1/2); <br><br>Incidence of wound infections<br>- Influence of ECC on AUC and other pharmacokinetic parameters.