Objective: To study the frequency of measurable gentamicin serum levels in patients with gentamicin PMMA-beads in situ.
ID
Source
Brief title
Condition
- Bacterial infectious disorders
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: Gentamicin serum level > 0,4 mg/l
Secondary outcome
• To determine specific patient groups at risk of developing gentamicin serum
levels > 0.4 mg/l after implantation of gentamicin PMMA-beads.
• To investigate the height of gentamicin serum levels after implantation of
gentamicin PMMA-beads.
• To investigate the duration of raised gentamicin serum levels > 0.4 mg/l.
• To investigate the occurrence of nephrotoxicity or other toxicities due to
gentamicin PMMA-beads.
• To relate the gentamicin serum level to the number of implanted beads
• Gentamicin serum level > 0.02 mg/l, measured with a modified TDxFLx method
Background summary
Rationale: According to the Septopal® (gentamicin PMMA-beads) SPC toxic
side-effects are not to be expected due tot the limited amount of systemically
available gentamicin. However, two recent cases have demonstrated that raised
gentamicin serum levels can indeed be detectable for a longer period of time
after implantation, which can lead to toxic side-effects. In this study we try
to obtain systemic gentamicin levels for every patient with newly implanted
gentamicin PMMA-beads in order to determine the frequency of measurable serum
levels.
Study objective
Objective: To study the frequency of measurable gentamicin serum levels in
patients with gentamicin PMMA-beads in situ.
Study design
Study design: Observational, prospective pharmacokinetic study
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: The burden for patients is the limited extra
amount of blood (maximum 30 ml) taken for measurement of gentamicin serum
levels during routine blood takings. Maximally 3 blood takings per patient are
required in this study.
De Run 4600
5504 DB Veldhoven
NL
De Run 4600
5504 DB Veldhoven
NL
Listed location countries
Age
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
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 | NL25363.015.08 |