xml: <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/NCT06021288</url>
    </required_header>
    <id_info>
      <org_study_id>AnIt23-06</org_study_id>
      <nct_id>NCT06021288</nct_id>
    </id_info>
    <brief_title>Standard Dose Continuous Renal Replacement Therapy (CRRT) Versus Low-Dose CRRT ( KETZEREI )</brief_title>
    <acronym>KETZEREI</acronym>
    <official_title>A Randomized Controlled Study Investigating Standard Dose Continuous Renal Replacement Therapy (CRRT) Versus Low-Dose CRRT - The &quot;Ketzerei&quot; Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Westfälische Wilhelms-Universität Münster</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Westfälische Wilhelms-Universität Münster</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Acute kidney injury (AKI) is a well-recognized complication in critically ill patients, which&#xD;
        often leads to the necessity of mechanical kidney support (CRRT).&#xD;
  &#xD;
        In current therapeutic regimes, CRRT is used to strictly prevent azotaemia. Thus recent&#xD;
        clinical observations, as well as data from animal testing suggest a link between controlled&#xD;
        azotaemia and faster renal recovery in AKI patients.&#xD;
  &#xD;
        The aim of the study is to improve renal recovery.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of days alive and free from CRRT</measure>
      <time_frame>Between Randomization and day 28</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of Adverse Events (rooted in uraemia, i.e. throwing up, seizures, uremic coma etc.)</measure>
      <time_frame>Between randomization and day 28</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of days with renal replacement therapy</measure>
      <time_frame>Between randomization and day 28</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of Intensive Care Unit (ICU) stay</measure>
      <time_frame>Between randomization and day 28</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of Hospital stay</measure>
      <time_frame>Between randomization and day 28</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mortality</measure>
      <time_frame>Day 30 after randomization</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of new infections since randomization</measure>
      <time_frame>From randomization until day 30</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total amount of dialysis fluid utilized adjusted for weight</measure>
      <time_frame>From randomization until day 30</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients alive and dialysis-free at day 30</measure>
      <time_frame>Day 30 after randomization</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Presence of Major adverse kidney events (MAKE)</measure>
      <time_frame>Day 30 after randomization</time_frame>
      <description>Composite endpoint consisting of death, renal replacement therapy, and persistent severe AKI lasting for 72 hours or more</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Expense of treatment (including hospital stay/all measures taken)</measure>
      <time_frame>From randomization until day 30 after randomization</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">165</enrollment>
    <condition>Critical Illness</condition>
    <condition>Acute Kidney Injury</condition>
    <arm_group>
      <arm_group_label>Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>CRRT will be established with a draining dose (effluent dose) of 10-15ml/kg/h in pursuit of establishing a controlled azotaemia.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Standard of Care:&#xD;
  CRRT will be established with a draining dose (effluent dose) of 25-30ml/kg/h</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Effluent dose of CRRT</intervention_name>
      <description>The effluent dose of the CRRT will be performed according to study group for 7 days or up to the end of CRRT, whatever occurs first.</description>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_label>Intervention Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients (age ≥18 years)&#xD;
  &#xD;
            -  Critically ill patients with AKI + in need of CRRT&#xD;
  &#xD;
            -  Written informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Chronic dialysis dependency&#xD;
  &#xD;
            -  Chronic kidney disease with estimated glomerular filtration rate (eGFR) &lt;30&#xD;
               ml/min/1.73m²&#xD;
  &#xD;
            -  severe liver cirrhosis (Child-pugh C)&#xD;
  &#xD;
            -  severe acidosis (pH &lt; 7,20 at study enrolment)&#xD;
  &#xD;
            -  severe hyperkalaemia (&gt; 6mmol/l)&#xD;
  &#xD;
            -  Pregnancy or breastfeeding&#xD;
  &#xD;
            -  persons held in an institution by legal or official order&#xD;
  &#xD;
            -  Dependency on the investigator or center&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Alexander Zarbock, MD</last_name>
      <role>Study Chair</role>
      <affiliation>WWU Münster</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alexander Zarbock, MD</last_name>
      <phone>+492518347255</phone>
      <email>aki@anit.uni-muenster.de</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Melanie Meersch-Dini, MD</last_name>
      <phone>+492518347255</phone>
      <email>aki@uni-muenster.de</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University Hospital Münster</name>
        <address>
          <city>Münster</city>
          <zip>48149</zip>
          <country>Germany</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Continuous renal replacement therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acute Kidney Injury</mesh_term>
      <mesh_term>Critical Illness</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06021288
  org study id: AnIt23-06
  nct id: NCT06021288
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Acute kidney injury (AKI) is a well-recognized complication in critically ill patients, which
        often leads to the necessity of mechanical kidney support (CRRT).
  
        In current therapeutic regimes, CRRT is used to strictly prevent azotaemia. Thus recent
        clinical observations, as well as data from animal testing suggest a link between controlled
        azotaemia and faster renal recovery in AKI patients.
  
        The aim of the study is to improve renal recovery.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Triple (Participant, Care Provider, Outcomes Assessor)
  measure: Number of days alive and free from CRRT
  time frame: Between Randomization and day 28
  measure: Number of Adverse Events (rooted in uraemia, i.e. throwing up, seizures, uremic coma etc.)
  time frame: Between randomization and day 28
  measure: Number of days with renal replacement therapy
  time frame: Between randomization and day 28
  measure: Length of Intensive Care Unit (ICU) stay
  time frame: Between randomization and day 28
  measure: Length of Hospital stay
  time frame: Between randomization and day 28
  measure: Mortality
  time frame: Day 30 after randomization
  measure: Number of new infections since randomization
  time frame: From randomization until day 30
  measure: Total amount of dialysis fluid utilized adjusted for weight
  time frame: From randomization until day 30
  measure: Number of patients alive and dialysis-free at day 30
  time frame: Day 30 after randomization
  measure: Presence of Major adverse kidney events (MAKE)
  time frame: Day 30 after randomization
  description: Composite endpoint consisting of death, renal replacement therapy, and persistent severe AKI lasting for 72 hours or more
  measure: Expense of treatment (including hospital stay/all measures taken)
  time frame: From randomization until day 30 after randomization
  arm group label: Intervention Group
  arm group type: Experimental
  description: CRRT will be established with a draining dose (effluent dose) of 10-15ml/kg/h in pursuit of establishing a controlled azotaemia.
  arm group label: Control Group
  arm group type: Active Comparator
  description: Standard of Care:
  CRRT will be established with a draining dose (effluent dose) of 25-30ml/kg/h
  intervention type: Other
  intervention name: Effluent dose of CRRT
  description: The effluent dose of the CRRT will be performed according to study group for 7 days or up to the end of CRRT, whatever occurs first.
  arm group label: Control Group
  arm group label: Intervention Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Alexander Zarbock, MD
  role: Study Chair
  affiliation: WWU Münster
  last name: Alexander Zarbock, MD
  phone: +492518347255
  email: aki@anit.uni-muenster.de
  last name: Melanie Meersch-Dini, MD
  phone: +492518347255
  email: aki@uni-muenster.de
  facility: 
  country: Germany
  responsible party type: Sponsor
  mesh term: Acute Kidney Injury
  mesh term: Critical Illness