Gentamicin serum levels with gentamicin impregnated PMMA-beads

Gentamicin serum levels with gentamicin impregnated PMMA-beads - Gentamicin serum levels with gentamicin impregnated PMMA-beads

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON35413

Enrollment

Registered

2009-02-02

Start date

2009-03-27

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

gentamicin serumlevels

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Orthopedic patients who will have gentamicin PMMA-beads implanted

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
Main study parameters/endpoints: Gentamicin serum level > 0,4 mg/l	—

Secondary

Measure	Time frame
• 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	—

Measure

Time frame

• 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

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Countries

Netherlands

Outcome results