NCT02242721

Drugmonitoring of Antiinfective Drugs in Patients Receiving Continous Veno-venous Hemodiafiltration (ABx-CVVHDF)

Drugmonitoring of Antiinfective Drugs in Patients Receiving Continous Veno-venous Hemodiafiltration

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: 1. To measure serum-concentrations of antiinfective drugs applied to the patients 2. To measure concentrations of antiinfective drugs in hemofiltration fluids. 3. To compare the actual measured concentrations with concentration predicted in known calculation tools. 4. To modify these calculation tools if necessary for better prediction.

Conditions

• Need for Renal Replacement Therapy and Anti-infective Therapy Due to Severe Infection

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-10-01
• Completion: 2016-01-01
• First posted: 2014-09-17
• Last updated: 2015-07-31

Locations

2 sites across 1 country: Germany