<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02242721</url>
  </required_header>
  <id_info>
    <org_study_id>ABx-CVVHDF</org_study_id>
    <nct_id>NCT02242721</nct_id>
  </id_info>
  <brief_title>Drugmonitoring of Antiinfective Drugs in Patients Receiving Continous Veno-venous Hemodiafiltration (ABx-CVVHDF)</brief_title>
  <official_title>Drugmonitoring of Antiinfective Drugs in Patients Receiving Continous Veno-venous Hemodiafiltration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Approximately 300 patients have to be enrolled in the study. They are followed up until the&#xD;
      end of ICU stay. Usually in clinical routine, patients suspected to have infection and&#xD;
      simultaneously renal dysfunction making CVVHDF necessary. After enrolment blood and dialysate&#xD;
      specimens are drawn and sent for analysis on specific time points. The analysis results are&#xD;
      sent back to the study team at the Charité - Universitätsmedizin Berlin and enable them to&#xD;
      optimize antiinfectiva treatment of the study patients.&#xD;
&#xD;
      Data are used to test calculation tools and modify them if necessary.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Little data exist whether desired and necessary blood levels of antiinfective drugs are&#xD;
      reached during renal replacement therapy. Drug producing companies are not able to come&#xD;
      forward with appropriate dosing recommendation in patients needing renal replacement therapy.&#xD;
&#xD;
      To achieve our study goal we plan:&#xD;
&#xD;
        1. To measure serum-concentrations of antiinfective drugs applied to the patients&#xD;
&#xD;
        2. To measure concentrations of antiinfective drugs in hemofiltration fluids.&#xD;
&#xD;
        3. To compare the actual measured concentrations with concentration predicted in known&#xD;
           calculation tools.&#xD;
&#xD;
        4. To modify these calculation tools if necessary for better prediction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">January 2016</completion_date>
  <primary_completion_date type="Anticipated">October 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Antibiotic clearance (l/h)</measure>
    <time_frame>Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>28-day mortality</measure>
    <time_frame>The 28-days mortality will be assessed on the 28th study day</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Need for Renal Replacement Therapy and Anti-infective Therapy Due to Severe Infection</condition>
  <arm_group>
    <arm_group_label>Intensive care unit patients needing renal replacement therapy</arm_group_label>
    <description>Male and female patients in the intensive care unit (ICU), needing renal replacement therapy due to renal dysfunction and are treated with antiinfective drugs.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples and Dialysate&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Critical ill patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients, age ≥ 18 years&#xD;
&#xD;
          -  Patients in the intensive care unit (ICU), needing renal replacement therapy due to&#xD;
             renal dysfunction and are treated with antiinfective drugs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy and lactation period.&#xD;
&#xD;
          -  Participation in a clinical intervention study&#xD;
&#xD;
          -  Lacking willingness to save and hand out data within the study&#xD;
&#xD;
          -  Accommodation in an institution due to an official or judicial order&#xD;
&#xD;
          -  The informed consent of the patient or the subject's legally acceptable representative&#xD;
             can´t be obtained in time&#xD;
&#xD;
          -  Patient has a power of attorney or patient's provision, where he/she refuses&#xD;
             participation in any clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical Department, Division of Nephrology, Campus Charité Mitte, Charité - Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacy, Kliniken Landkreis Heidenheim gGmbH</name>
      <address>
        <city>Heidenheim</city>
        <zip>89522</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>July 30, 2015</last_update_submitted>
  <last_update_submitted_qc>July 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 31, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Claudia Spies</investigator_full_name>
    <investigator_title>Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte and Campus Virchow - Klinikum</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02242721
org study id: ABx-CVVHDF
nct id: NCT02242721
lead sponsor: 
has dmc: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Antibiotic clearance (l/h)
time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
measure: 28-day mortality
time frame: The 28-days mortality will be assessed on the 28th study day
arm group label: Intensive care unit patients needing renal replacement therapy
description: Male and female patients in the intensive care unit (ICU), needing renal replacement therapy due to renal dysfunction and are treated with antiinfective drugs.
Blood samples and Dialysate
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Claudia Spies
investigator title: Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte and Campus Virchow - Klinikum