Gentamicin serum levels with gentamicin impregnated PMMA-beads

Completed

• Conditions: gentamicin serumlevels; 10004018; 10023213; 10005944

• Registration Number: NL-OMON35413
• Lead Sponsor: ziekenhuisapotheek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Orthopedic patients who will have gentamicin PMMA-beads implanted

Exclusion Criteria

• Administration of gentamicin in any other way then implantation of gentamicin PMMA-beads seven days prior to the first taking of gentamicin serum level up to taking of the final gentamicin serum level for this study.
• Legally incapable patients
• Patients under the age of 18 years old
- Breastfeeding women
- Pregnant women
- Allergy to aminoglycosides

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters/endpoints: Gentamicin serum level > 0,4 mg/l </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• To determine specific patient groups at risk of developing gentamicin serum<br /><br>levels > 0.4 mg/l after implantation of gentamicin PMMA-beads.<br /><br>• To investigate the height of gentamicin serum levels after implantation of<br /><br>gentamicin PMMA-beads.<br /><br>• To investigate the duration of raised gentamicin serum levels > 0.4 mg/l.<br /><br>• To investigate the occurrence of nephrotoxicity or other toxicities due to<br /><br>gentamicin PMMA-beads.<br /><br>• To relate the gentamicin serum level to the number of implanted beads<br /><br>• Gentamicin serum level > 0.02 mg/l, measured with a modified TDxFLx method</p><br>