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

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

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02242721
• Other study ID #: ABx-CVVHDF
• Status: Withdrawn
• Phase: N/A
• First received: September 8, 2014
• Last updated: July 30, 2015
• Start date: October 2014
• Est. completion date: January 2016

Study information

• Verified date: July 2015
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Germany	Medical Department, Division of Nephrology, Campus Charité Mitte, Charité - Universitätsmedizin Berlin	Berlin
Germany	Pharmacy, Kliniken Landkreis Heidenheim gGmbH	Heidenheim

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibiotic clearance (l/h)		Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days	No
Secondary	28-day mortality		The 28-days mortality will be assessed on the 28th study day	No