Pharmacokinetics of Selected Antiinfectives During Sustained Low-efficiency Dialysis (SLED)

Study Overview
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Brief Summary
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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
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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

Official Title
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Pharmacokinetics of Selected Antiinfectives During Sustained Low-efficiency Dialysis (SLED)

Conditions
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Replacement Therapy, Renal

Intervention / Treatment
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* Other: Pharmacokinetic Analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age: 18 or older patients receiving SLED and either meropenem or ceftazidim Exclusion Criteria: missing informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Meropenem<br>Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics. | Other: Pharmacokinetic Analysis<br> <br> |
| Ceftazidim<br>Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics. | Other: Pharmacokinetic Analysis<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients Showing Serum Levels of Meropenem or Ceftazidim at the End of SLED Above the Minimal Inhibitory Concentration (MIC) | 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. | days receiving SLED, up to 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | ICU mortality | minimum duration of hospital stay, maximum 1 year | 
| Length of Stay (LOS) | Length of stay at the ICU and in hospital | minimum duration of hospital stay, maximum 1 year | 
| Number of Patients With Clinical Cure of Infections | Clinical response to antibiotic treatment assessed by laboratory parameters such as leucocyte count, c-reactive protein or procalcitonin levels as well as vasopressor support | minimum duration of hospital stay, maximum 1 year |