Pharmacokinetics of cefuroxime in bone and cartilage
- Conditions
- The pharmacokinetics of cefuroxime in the human body will be investigated
- Registration Number
- DRKS00012880
- Lead Sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Adult Patients
women and men
from 20 to 85 years
undergoing an elective hip replacement therapy
or spine surgery
Signed informed study consent form
Legally competent patient
Subject exclusion criteria:
Patients who are unable to consent
Patients unwilling to consent
Patients who retracted their consent
Pregnant women,
Patients with impaired renal or liver function,
Patients with anemia,
Children
Young adults that are still growing
Breast-feeding women,
Patients with leucocytopenia,
Patients with thrombocytopenia
Patients hypersensitive or allergic to cefuroxime, cephalosporines or beta-lactame antibiotics
Patients with prior traumatic surgery within six month
Patients with past or present osteomyelitis
Patients with impaired cardiac function
Patients with high body mass index
Patients taking diuretics or aminoglycoside antibiotics
Patients with candida infections
Patients with colitis
Patients with other abdominal infections
Patients with abdominal infection
Patients receiving an additional administration of cefuroxime due to longer duration of surgery or other clinical reasons within the sample collecting period
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The endpoint of the study is the calculated concentrations of cefuroxime in the different tissues taken at different times. The concentration is determined by high performance liquid chromatography (HPLC). This analysis is started when all 80 patients have been discharged from the hospital.
- Secondary Outcome Measures
Name Time Method does not apply