Investigation on the influence of the multifiltrate dialysis method on the serum levels of antibiotics in dialysis intensive care patients using the example of fosfomyci
- Conditions
- Infections caused by fosfomycin-sensitive pathogensAcute or acute-to-chronic renal failure requiring continuous dialysis treatment
- Registration Number
- DRKS00017450
- Lead Sponsor
- Infectopharm Arzneimittel und Consilium GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 15
Written consent of the patient or his legal guardian, patients > 18 years, acute renal failure with indication for continuous renal replacement therapy, patient already receives fosfomycin or the dose is planned for medical indication, Central venous catheter for taking blood samples have already been placed for medical indication, BMI < 35, for women of childbearing potential: negative pregnancy test, or surgical sterilization or contraceptive use during the examination or min. 2 years after postmenopause.
Refusal by the patient, contraindications or known intolerance to any of the drugs or procedures used, pre-existing conditions or patient circumstances that make a patient's examination impossible or meaningless (eg, dementia, psychiatric disorders, poor speech understanding or speaking ability), body mass index > 35, pregnancy.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma concentration course of fosfomycin with and without multifiltration dialysis<br>1. before first start<br>2. 15 minutes after first start<br>3. 30 min after first start<br>4. 60 min after first start<br>5. 90 minutes after first start<br>6. 120 min after first start<br>7. 180 minutes after first start<br>8. 240 minutes after first start<br>9. 300 min after first start<br>10. 360 minutes after first start
- Secondary Outcome Measures
Name Time Method Change in distribution volumes and clearance values; Correlation between fosfomycin dosage and plasma concentrations taking into account the cofactors: acute renal failure, multifiltration dialysis, fosfomycin concentration in dialysis filtrate. Endpoints are calculated after completion of all plasma measurements within a pharmacokinetic model.