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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00030889
Enrollment
30
Registered
2023-06-27
Start date
2023-06-29
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I25 T98

Interventions

Group 1: Patients undergoing elective bypass surgery using extracorporeal circulation who require perioperative antibiotic prophylaxis. Group 2: Patients undergoing elective bypass surgery without the

Sponsors

Universitätsklinikum Augsburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Contacts

Public ContactPhilipp Simon

Universitätsklinikum Augsburg

philipp.simon3@uk-augsburg.de+498214002378

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026