Cefazolin plasma levels and pharmacokinetic parameters during adult cardiac surgery: after implementation of a new protocol for antibiotic prophylaxis.

Completed

• Conditions: Cardiac Surgery; open hart operation; 10011082; 10004018; 10007593

• Registration Number: NL-OMON48705
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

Informed consent
Age >18 year
Cardiac surgery with the use of CPB
Use of cefazolin as antibiotic prophylaxis
BMI <40

Exclusion Criteria

No informed consent
Age <18 years
Cardiac surgery without use of CPB
Known allergy to cefazolin
BMI >40
Active infection treated with antibiotics before surgery
Kidney function impairment, defined as eGFR <35 ml/min
Liver function impairment, defined as ASAT or ALAT >3 times normal values.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Time and concentration of cefazolin above the MIC of 2 mg/L.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* PK parameters on cefazolin in patients undergoing cardiac surgery<br /><br><br /><br>Incidence of DSWI and concomitant use of antibiotics will be recorded in the<br /><br>database. We will not include incidence of DSWI as an secondary objective,<br /><br>since this is a rare complication and the study design in not suited to<br /><br>investigate this. Data on kidney and liver impairment (as defined in exclusion<br /><br>criteria) post-operatively will also be recorded in the database. </p><br>