The primary aim of the study of to investigate time and concentration of cefazolin above the MIC. The main secondary aim is to investigate influence of cardiac surgery and use of CPB on PK parameters of cefazolin. We aim investigate the new dosing…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Bacterial infectious disorders
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Time and concentration of cefazolin above the MIC of 2 mg/L.
Secondary outcome
* PK parameters on cefazolin in patients undergoing cardiac surgery
Incidence of DSWI and concomitant use of antibiotics will be recorded in the
database. We will not include incidence of DSWI as an secondary objective,
since this is a rare complication and the study design in not suited to
investigate this. Data on kidney and liver impairment (as defined in exclusion
criteria) post-operatively will also be recorded in the database.
Background summary
Cefazolin is a first-generation cephalosporin and widely used as peri-operative
antibiotic prophylaxis to prevent deep sternal and post-operative wound
infections. Deep sternal wound infection is a rare but severe complication, and
is associated with prolonged hospital stay, subsequent surgery and increased
morbidity and mortality.
The guideline for the use of cefazolin as antibiotic prophylaxic comes from the
Dutch Antibiotic Taskforce (SWAB-Stichting Werkgroep Antibioticabeleid). Within
several months, the antibiotic guideline will be changed. The peri-operative
cefazolin dose at onset of the CPB will be withdrawn and the doses of several
peri-operative and post-operative bolus will be decreased. Both for the old and
new protocol very limited data is available to determine if adequate cefazolin
plasma levels (above the 2 mg/L Minimal Inhibitory Concentration) are achieved.
If the proposed decreased cefazolin dose does not achieve adequate plasma
levels, patients will be at increased risk for developing post-operative
infections.
Study objective
The primary aim of the study of to investigate time and concentration of
cefazolin above the MIC. The main secondary aim is to investigate influence of
cardiac surgery and use of CPB on PK parameters of cefazolin.
We aim investigate the new dosing guidelines and to provide more evidence for
an evidence-based dosing regimen.
Study design
prospective, observational study
Intervention
New guideline for peri- and postoperative antibiotic prophylaxes: withholding
dose at start CPB, postoperative dose at 8 and 16 hours from 1 gram cefazoline
Study burden and risks
Patients do not benefit from participating in the study. However, since
patients receive standard treatment and the blood measurements are
non-invasive, patient also have no harm from participating in the study. No
risks for the patients are to be expected when participating in the study.
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL67109.078.18 |
| Other | trials.gov registratie volgt |