Drugmonitoring of Antiinfective Drugs in Patients Receiving Continous Veno-venous Hemodiafiltration (ABx-CVVHDF)
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|ClinicalTrials.gov Identifier: NCT02242721|
Recruitment Status : Withdrawn
First Posted : September 17, 2014
Last Update Posted : July 31, 2015
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.
|Condition or disease|
|Need for Renal Replacement Therapy and Anti-infective Therapy Due to Severe Infection|
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.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Drugmonitoring of Antiinfective Drugs in Patients Receiving Continous Veno-venous Hemodiafiltration|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||January 2016|
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.
- Antibiotic clearance (l/h) [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
- 28-day mortality [ Time Frame: The 28-days mortality will be assessed on the 28th study day ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02242721
|Medical Department, Division of Nephrology, Campus Charité Mitte, Charité - Universitätsmedizin Berlin|
|Berlin, Germany, 10117|
|Pharmacy, Kliniken Landkreis Heidenheim gGmbH|
|Heidenheim, Germany, 89522|