Pharmacokinetics of Selected Antiinfectives During Sustained Low-efficiency Dialysis (SLED)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Replacement Therapy, Renal
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Patients Showing Serum Levels of Meropenem or Ceftazidim at the End of SLED Above the Minimal Inhibitory Concentration (MIC)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
In a prospective, non-interventional, monocentric observational study the pharmacokinetic properties of selected antiinfective drugs during sustained low-efficiency dialysis (SLED) will be analyzed.
Detailed Description
Antibiotic concentrations are measured whilst patients receive SLED for renal replacement therapy. The plasma specimens will be quantified using high Performance liquid chromatography (HPLC). Primary endpoint: - Plasma levels of antiinfectives during SLED Secondary endpoints: * mortality * length of stay at the intensive care unit (ICU) and hospital * clinical cure of infections Inclusion criteria: * age: \> 18 years * patients under SLED * antiinfective treatment exclusion criteria: - missing informed consent
Investigators
PD Dr. rer. medic. Claudia Langebrake
Head Clinical Research Hospital Pharmacy
Universitätsklinikum Hamburg-Eppendorf
Eligibility Criteria
Inclusion Criteria
- •age: 18 or older
- •patients receiving SLED and either meropenem or ceftazidim
Exclusion Criteria
- •missing informed consent
Outcomes
Primary Outcomes
Patients Showing Serum Levels of Meropenem or Ceftazidim at the End of SLED Above the Minimal Inhibitory Concentration (MIC)
Time Frame: days receiving SLED, up to 5 days
Plasma concentrations of meropenem or ceftazidim by the end of SLED therapy. Meropenem and ceftazidim are often used for empirical treatment also targeting for Pseudomonas aeruginosa (PSA) infections. Therefore, minimal targeted concentrations were set to the MIC of 2 mg/l for meropenem and to the MIC of 4 mg/L for ceftazidime treatment according to the breakpoints of PSA strains.
Secondary Outcomes
- Length of Stay (LOS)(minimum duration of hospital stay, maximum 1 year)
- Mortality(minimum duration of hospital stay, maximum 1 year)
- Number of Patients With Clinical Cure of Infections(minimum duration of hospital stay, maximum 1 year)