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/NCT06014801</url>
    </required_header>
    <id_info>
      <org_study_id>JKI23-002</org_study_id>
      <secondary_id>jRCTs031230292</secondary_id>
      <nct_id>NCT06014801</nct_id>
    </id_info>
    <brief_title>Low-intensity Versus Medium-intensity Continuous Kidney Replacement Therapy for Critically Ill Patients</brief_title>
    <acronym>LIMIT</acronym>
    <official_title>Low-Intensity Versus Medium-Intensity Continuous Kidney Replacement Therapy for Critically Ill Patients (LIMIT): A Multicenter Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jikei University School of Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Fukui</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Tsuchiura Kyodo General Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Keio University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Wakayama Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Jichi Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Jikei University School of Medicine</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>
        This clinical trial aims to investigate whether the low treatment intensity (12 mL/kg/hr,&#xD;
        low-dose hemodialysis/filtration) or the medium treatment intensity (25 mL/kg/hr,&#xD;
        standard-dose hemodialysis/filtration) is more effective and safer for continuous renal&#xD;
        replacement therapy in critically ill patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2026</completion_date>
    <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
    <phase>Phase 2/Phase 3</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>28-day kidney replacement therapy free days</measure>
      <time_frame>28 days or hospital discharge whichever comes first</time_frame>
      <description>Composite endpoint of death and duration of kidney replacement therapy at 28 days</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>ICU mortality</measure>
      <time_frame>90 days or hospital discharge whichever comes first</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospital mortality</measure>
      <time_frame>90 days or hospital discharge whichever comes first</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dialysis dependence at hospital discharge</measure>
      <time_frame>90 days or hospital discharge whichever comes first</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>28-day vasopressor-free days</measure>
      <time_frame>28 days or hospital discharge whichever comes first</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>28-day ventilator-free days</measure>
      <time_frame>28 days or hospital discharge whichever comes first</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum creatinine level at the end of kidney replacement therapy</measure>
      <time_frame>90 days or hospital discharge whichever comes first</time_frame>
      <description>Serum creatinine level on the day of final kidney replacement therapy and the day before</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>24-hour urine output at the end of kidney replacement therapy</measure>
      <time_frame>90 days or hospital discharge whichever comes first</time_frame>
      <description>24-hour urine output on the day of final kidney replacement therapy and the day before</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Hypokalemia</measure>
      <time_frame>up to 7 days of continuous kidney replacement therapy</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Hypophosphatemia</measure>
      <time_frame>up to 7 days of continuous kidney replacement therapy</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Sodium bicarbonate solutions that administered</measure>
      <time_frame>up to 7 days of continuous kidney replacement therapy</time_frame>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Acute Kidney Injury Requiring Continuous Renal Replacement Therapy</condition>
    <arm_group>
      <arm_group_label>Low intensity</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Effluent rate of 12 mL/kg/hr</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Medium intensity</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Effluent rate of 25 mL/kg/hr</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dialysate fluid, Filtration replacement fluid</intervention_name>
      <description>Dose of continuous hemodialysis and/or hemofiltration</description>
      <arm_group_label>Low intensity</arm_group_label>
      <arm_group_label>Medium intensity</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria: Patient who meets all of the following criteria and who has given&#xD;
          informed consent.&#xD;
  &#xD;
            1. Adults (18 years of age or older, regardless of the time since ICU admission)&#xD;
               currently admitted to an intensive care unit*.&#xD;
  &#xD;
               *Includes high care units, where continuous monitoring is conducted and intensive care&#xD;
               physicians are in charge of medical care.&#xD;
  &#xD;
            2. A diagnosis of acute kidney injury is made according to the Kidney Disease: Improving&#xD;
               Global Outcomes (KDIGO) international diagnostic criteria (one of the following is&#xD;
               met)&#xD;
  &#xD;
                 -  Serum creatinine increased by more than 0.3 mg/dL within 48 hours&#xD;
  &#xD;
                 -  Serum creatinine increased more than 1.5-fold from baseline and the increase is&#xD;
                    considered to have occurred within 7 days&#xD;
  &#xD;
                 -  Oliguria (&lt; 0.5 mL/kg/hr) lasting more than 6 hours&#xD;
  &#xD;
            3. The treating intensivist believes that continuous kidney replacement therapy is&#xD;
               necessary&#xD;
  &#xD;
          Exclusion Criteria: Patient who meets any of the following exclusion criteria will be&#xD;
          excluded.&#xD;
  &#xD;
            1. Receiving chronic dialysis or scheduled for initiation of chronic dialysis&#xD;
  &#xD;
            2. Undergoing any kidney replacement therapy or blood purification therapy within 48&#xD;
               hours&#xD;
  &#xD;
            3. When kidney replacement therapy using other dialysate or replacement fluids, such as&#xD;
               citrate dialysis, is preferred due to coexisting bleeding disorders or allergy to&#xD;
               acetate&#xD;
  &#xD;
            4. Concomitant blood purification therapy other than hemofiltration/dialysis, such as&#xD;
               plasma exchange&#xD;
  &#xD;
            5. The patient is in a very critical condition and the treating physician believes that&#xD;
               survival for more than 24 hours is unlikely&#xD;
  &#xD;
            6. Previous participation in the study&#xD;
  &#xD;
            7. After receiving a full explanation of the study and with full understanding, a patient&#xD;
               do not consent to participate in the study of their own (or their substitute decision&#xD;
               maker's) will.&#xD;
  &#xD;
            8. The principal investigator (or an investigator) thinks it to be inappropriate to&#xD;
               participate in this study.&#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>Tomoko Fujii, MD,PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Jikei University School of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Tomoko Fujii, MD,PhD</last_name>
      <phone>+81 3 3433 1111</phone>
      <email>tofujii-tky@umin.net</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Jikei University School of Medicine</investigator_affiliation>
      <investigator_full_name>Tomoko Fujii</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acute Kidney Injury</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dialysis Solutions</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06014801
  org study id: JKI23-002
  secondary id: jRCTs031230292
  nct id: NCT06014801
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This clinical trial aims to investigate whether the low treatment intensity (12 mL/kg/hr,
        low-dose hemodialysis/filtration) or the medium treatment intensity (25 mL/kg/hr,
        standard-dose hemodialysis/filtration) is more effective and safer for continuous renal
        replacement therapy in critically ill patients.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: 28-day kidney replacement therapy free days
  time frame: 28 days or hospital discharge whichever comes first
  description: Composite endpoint of death and duration of kidney replacement therapy at 28 days
  measure: ICU mortality
  time frame: 90 days or hospital discharge whichever comes first
  measure: Hospital mortality
  time frame: 90 days or hospital discharge whichever comes first
  measure: Dialysis dependence at hospital discharge
  time frame: 90 days or hospital discharge whichever comes first
  measure: 28-day vasopressor-free days
  time frame: 28 days or hospital discharge whichever comes first
  measure: 28-day ventilator-free days
  time frame: 28 days or hospital discharge whichever comes first
  measure: Serum creatinine level at the end of kidney replacement therapy
  time frame: 90 days or hospital discharge whichever comes first
  description: Serum creatinine level on the day of final kidney replacement therapy and the day before
  measure: 24-hour urine output at the end of kidney replacement therapy
  time frame: 90 days or hospital discharge whichever comes first
  description: 24-hour urine output on the day of final kidney replacement therapy and the day before
  measure: Hypokalemia
  time frame: up to 7 days of continuous kidney replacement therapy
  measure: Hypophosphatemia
  time frame: up to 7 days of continuous kidney replacement therapy
  measure: Sodium bicarbonate solutions that administered
  time frame: up to 7 days of continuous kidney replacement therapy
  arm group label: Low intensity
  arm group type: Experimental
  description: Effluent rate of 12 mL/kg/hr
  arm group label: Medium intensity
  arm group type: Active Comparator
  description: Effluent rate of 25 mL/kg/hr
  intervention type: Drug
  intervention name: Dialysate fluid, Filtration replacement fluid
  description: Dose of continuous hemodialysis and/or hemofiltration
  arm group label: Low intensity
  arm group label: Medium intensity
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Tomoko Fujii, MD,PhD
  role: Study Chair
  affiliation: Jikei University School of Medicine
  last name: Tomoko Fujii, MD,PhD
  phone: +81 3 3433 1111
  email: tofujii-tky@umin.net
  responsible party type: Principal Investigator
  investigator affiliation: Jikei University School of Medicine
  investigator full name: Tomoko Fujii
  investigator title: Professor
  mesh term: Acute Kidney Injury
  mesh term: Dialysis Solutions
  sharing ipd: Yes