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.

Study Overview

• Status: Withdrawn
• Conditions: Need for Renal Replacement Therapy and Anti-infective Therapy Due to Severe Infection

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Medical Department, Division of Nephrology, Campus Charité Mitte, Charité - Universitätsmedizin Berlin
  • Heidenheim, Germany, 89522
    • Pharmacy, Kliniken Landkreis Heidenheim gGmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Critical ill patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Antibiotic clearance (l/h)	Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days

Secondary Outcome Measures

Outcome Measure	Time Frame
28-day mortality	The 28-days mortality will be assessed on the 28th study day

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): October 1, 2015
• Study Completion (Anticipated): January 1, 2016

Study Registration Dates

• First Submitted: September 8, 2014
• First Submitted That Met QC Criteria: September 15, 2014
• First Posted (Estimate): September 17, 2014

Study Record Updates

• Last Update Posted (Estimate): July 31, 2015
• Last Update Submitted That Met QC Criteria: July 30, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: ABx-CVVHDF