2012_PharmacoCRRT-study:Pharmacokinetics of Anti-infectives in Critically Ill Patients in Need of Continuous Renal Replacement Therapy (CRRT)

Study Overview
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Brief Summary
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The main purpose of the study is to examine if changes in pharmacokinetics of important antiinfectives in Critically Ill patients in need of continuous renal replacement therapy (CRRT), causes inadequate concentrations in plasma. The effect of different modus of CRRT: CVVH and CVVHD will be compared, as well as type of filter, filter lifetime etc. Hypothesis: The risk of incorrect dosage of antiinfectives - to low/ to high- is increased in critically ill patients receiving CRRT. Inadequate plasma concentrations of antiinfectives may contribute to increased mortality in this group.

Detailed Description
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The main purpose of the study is to examine if changes in pharmacokinetics of important antiinfectives in Critically Ill patients in need of continuous renal replacement therapy (CRRT), causes inadequate concentrations in plasma. The effect of different modus of CRRT: CVVH and CVVHD will be compared, as well as type of filter, filter lifetime etc. Hypothesis: The risk of incorrect dosage of antiinfectives - to low/ to high- is increased in critically ill patients receiving CRRT. Inadequate plasma concentrations of antiinfectives may contribute to increased mortality in this group. The antiinfectives to be examined are meropenem, fluconazol, cefotaxim, ciprofloxacin, tazobactam-piperacillin, vancomycin,penicillin,cloxacillin. Endpoints: Measured plasma concentrations of antiinfectives are sufficient for maximal microbial killing. To identify the most important variability factors for plasma concentrations of antiinfectives in patients receiving CRRT Establish and validate a routine for measurement of vital antiinfectives.

Official Title
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Pharmacokinetics of Anti-infectives in Critically Ill Patients in Need of Continuous Renal Replacement Therapy (CRRT) or Without CRRT

Conditions
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Critically Ill, Acute Renal Failure, Acute Kidney Injury

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted to ICU in need of antiinfectives: in need of CRRT without acute kidney failure requirement for antiinfectives> 72 hrs Age > 18 yrs signed informed consent Exclusion Criteria: Acute or chronic renal failure not in need of CRRT Age < 18 yrs

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 |
| --- | --- |
| antiinfectiva: vancomycin<br>80 patients Completed. | |
| antiinfectiva: meropenem<br>80 patients recruiting | |
| antiinfectiva: flukonazol<br>80 patients | |
| antiinfectiva: cefotaxim<br>80 patients | |
| antiinfectiva: benzylpenicilline<br>80 patients | |
| antiinfectiva: tazobactam piperacillin<br>80 patients recruiting | |
| antiinfectiva: cloxacillin<br>80 patients | |
| antiinfectiva: ciprofloxacin<br>80 patients | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sub-therapeutic levels of measured antiinfectiva | Pharmacokinetic/pharmacodynamic index achieved for each antiinfectiva | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SOFA-score | Sequential organ failure assessment, first 3 days after initiation of therapy | 72 hrs | 
| Mortality |  | 90-days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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critical illness, pharmacokinetics, CRRT, CVVH, CVVHD, CVVHDF, antiinfectives, antibiotics, minimum inhibitory concentration, bacterial killing, pharmacodynamics, PK/PD index