hip replacement
Conditions
Interventions
Trade Name: Cetriaxon
Product Name: ceftriaxon
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: ceftriaxon
Concentration unit: g gram(s)
Concentration type: equal
Sponsors
Institut for Pharmacology and Toxicology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: We will include patients (women and men) from 40 to 65 years which are, for clinical reasons, undergoing a hip replacement therapy in the participating centre. The patients must be able to understand and sign informed consent that the patient is willing to participate in the study. Women must be postmenopausal. We will use only patients with no relevant and accompanying diseases like: prior traumatic surgery past or present osteomyelitis impaired function of the heart ( > NYHA II) impaired function of the kidney (creatinine > 1,5 mg/ml) impaired function of the liver (high GOT-value) high body mass index (BMI > 35) allergy against cephalosporine allergy against ß-lactame-antibiotics Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who are unable to consent will not be included in the study. Based on the literature, cephalosporine can be used in pregnancy. For safety reasons premenopausal women will be excluded from this trial. We will exclude patients with relevant and accompanying diseases like: prior traumatic surgery past or present osteomyelitis impaired function of the heart ( > NYHA II) impaired function of the kidney (creatinine > 1,5 mg/ml) impaired function of the liver (high GOT-value) high body mass index (BMI > 35) allergy against cephalosporine allergy against ß-lactame-antibiotics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: bone and plasma concentration of antibiotics;Secondary Objective: does not apply;Primary end point(s): The potential benefit of the study could be the identification of criteria for the development of new antibiotics that would be better than the currently used for the prophylaxes of bone infection in patients. The aim of the current application is a correlation between the time of application, the dosing and the plasma levels of Ceftriaxon in relation to its concentrations in sub regions of the hip. It is routine to apply Ceftriaxon before hip replacement surgery is started. | — |
Countries
Germany
Outcome results
None listed