Drugmonitoring of Antiinfective Drugs in Patients Receiving Continous Veno-venous Hemodiafiltration (ABx-CVVHDF)
Drugmonitoring of Antiinfective Drugs in Patients Receiving Continous Veno-venous Hemodiafiltration
Approximately 300 patients have to be enrolled in the study. They are followed up until the end of ICU stay. Usually in clinical routine, patients suspected to have infection and simultaneously renal dysfunction making CVVHDF necessary. After enrolment blood and dialysate specimens are drawn and sent for analysis on specific time points. The analysis results are sent back to the study team at the Charité - Universitätsmedizin Berlin and enable them to optimize antiinfectiva treatment of the study patients.
Data are used to test calculation tools and modify them if necessary.
Studieöversikt
Status
Detaljerad beskrivning
Little data exist whether desired and necessary blood levels of antiinfective drugs are reached during renal replacement therapy. Drug producing companies are not able to come forward with appropriate dosing recommendation in patients needing renal replacement therapy.
To achieve our study goal we plan:
- To measure serum-concentrations of antiinfective drugs applied to the patients
- To measure concentrations of antiinfective drugs in hemofiltration fluids.
- To compare the actual measured concentrations with concentration predicted in known calculation tools.
- To modify these calculation tools if necessary for better prediction.
Studietyp
Kontakter och platser
Studieorter
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Berlin, Tyskland, 10117
- Medical Department, Division of Nephrology, Campus Charité Mitte, Charité - Universitätsmedizin Berlin
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Heidenheim, Tyskland, 89522
- Pharmacy, Kliniken Landkreis Heidenheim gGmbH
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Male and female patients, age ≥ 18 years
- Patients in the intensive care unit (ICU), needing renal replacement therapy due to renal dysfunction and are treated with antiinfective drugs
Exclusion Criteria:
- Pregnancy and lactation period.
- Participation in a clinical intervention study
- Lacking willingness to save and hand out data within the study
- Accommodation in an institution due to an official or judicial order
- The informed consent of the patient or the subject's legally acceptable representative can´t be obtained in time
- Patient has a power of attorney or patient's provision, where he/she refuses participation in any clinical trial
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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Intensive care unit patients needing renal replacement therapy
Male and female patients in the intensive care unit (ICU), needing renal replacement therapy due to renal dysfunction and are treated with antiinfective drugs.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Antibiotic clearance (l/h)
Tidsram: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
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Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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28-day mortality
Tidsram: The 28-days mortality will be assessed on the 28th study day
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The 28-days mortality will be assessed on the 28th study day
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Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- ABx-CVVHDF
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