Elimination of Antibiotics During Renal Replacement Therapy and Cytosorb Adsorptive Therapy

Study Overview
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Brief Summary
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Cytokine adsorption using the cytosorb adsorber is currently investigated to reduce the levels of proinflammatory cytokines in patients with severe sepsis and septic shock. The adsorber is frequently used in series with continuous renal replacement therapy. Up to date, no data on the removal of antibiotic drugs during combined renal replacement therapy and cytokine adsorptive therapy is available. Therefore, we want to investigate - whether and to what extent antibiotic drugs (piperacillin/tazobactam and imipenem/cilastatin) are removed during combined continuous renal replacement therapy and cytosorb adsorption in patients with severe sepsis and septic shock

Detailed Description
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Patients in this trial are undergoing renal replacement therapy as part of their routine care. Thus, this is an observational trial.

Official Title
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Elimination of Antibiotics During Combined Continuous Renal Replacement Therapy and Cytosorb Adsorptive Therapy in Patients With Sepsis and Acute Kidney Injury

Conditions
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Critical Illness, Sepsis, Acute Kidney Injury

Intervention / Treatment
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* Other: Monitoring of antibiotic drug removal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Intensive care patients with severe sepsis or septic shock and acute kidney injury requiring continuous renal replacement therapy and cytokine adsorption Age > 18 y Exclusion Criteria: < 18 y Pregnancy Contraindications against citrate-anticoagulation or continuous renal replacement therapy or cytokine adsorption

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 |
| --- | --- |
| Piperacillin/Tazobactam<br>Critically ill patients teated with piperacillin/tazobactam undergoing renal replacement therapy and cytosorb absorption during sepsis | Other: Monitoring of antibiotic drug removal<br>* No study specific intervention will be performed<br>|
| Imipenem/Cilastatin<br>Critically ill patients teated with imipenem/cilastatin undergoing renal replacement therapy and cytosorb absorption during sepsis | Other: Monitoring of antibiotic drug removal<br>* No study specific intervention will be performed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Removal of antibiotic drugs during the first 8 hours of combined continuous renal replacement therapy and cytosorb adsorption | Removal of antibiotic drugs during combined CRRT and adsorption will be evaluated by calculating total filter clearance using the drug concentration pre- and postfilter as well as the dialysate concentration. The adsorptive clearance will be evaluated using the pre- and postadsorber concentration. The outcome measure will be removal of antibiotic drug [mg/8 h dosing interval]. | 8 hours |