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/NCT05982340</url>
    </required_header>
    <id_info>
      <org_study_id>03055 PVO</org_study_id>
      <nct_id>NCT05982340</nct_id>
    </id_info>
    <brief_title>Endogenous Lithium Clearance in Acute Kidney Injury</brief_title>
    <official_title>Endogenous Lithium Clearance in Acute Kidney Injury</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital of North Norway</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital of North Norway</source>
    <oversight_info>
      <has_dmc>No</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>
        Critically ill patients are at high risk of developing acute kidney injury (AKI). Lithium is&#xD;
        freely filtrated at the glomerulus and almost completely reabsorbed in the proximal tubule,&#xD;
        which provides a quantitative estimation of proximal tubule reabsorption. We hypothesized&#xD;
        that endogenous lithium reabsorption is impaired in the early stages of critical illness.&#xD;
  &#xD;
        We would like to study 10 ICU patients with AKI diagnosed, 10 patients without AKI, and 10&#xD;
        healthy controls. Blood and urine samples will be obtained at 08:00, 14:00 and 20:00 during&#xD;
        one day. Renal clearance of creatinine (CCr) and lithium will be calculated.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Lithium clearance</measure>
      <time_frame>2 days</time_frame>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Acute Kidney Injury Due to Sepsis</condition>
    <condition>Proximal Tubule Function</condition>
    <condition>Lithium Clearance</condition>
    <arm_group>
      <arm_group_label>Group 1</arm_group_label>
      <description>ICU patients with AKI</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2</arm_group_label>
      <description>ICU patients with normal renal function</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 3</arm_group_label>
      <description>Healthy controls</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Lithium clearance</intervention_name>
      <description>Blood and urine samples</description>
      <arm_group_label>Group 1</arm_group_label>
      <arm_group_label>Group 2</arm_group_label>
      <arm_group_label>Group 3</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Urine and blood&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Critically ill patients and healthy controls&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ICU patients diagnosed with AKI, without AKI and healthy controls&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Lars Marius Ytrebø</last_name>
      <phone>90788058</phone>
      <email>lars.marius.ytrebo@unn.no</email>
    </overall_contact>
    <location>
      <facility>
        <name>University Hospital of North Norway</name>
        <address>
          <city>Tromsø</city>
          <state>Troms</state>
          <zip>9038</zip>
          <country>Norway</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lars M Ytrebø, MD PhD</last_name>
        <phone>+47 90788058</phone>
        <email>lars.marius.ytrebo@unn.no</email>
      </contact>
      <investigator>
        <last_name>Kjellbjorn Jakobsen, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Norway</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acute Kidney Injury</mesh_term>
      <mesh_term>Wounds and Injuries</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lithium Carbonate</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT05982340
  org study id: 03055 PVO
  nct id: NCT05982340
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Critically ill patients are at high risk of developing acute kidney injury (AKI). Lithium is
        freely filtrated at the glomerulus and almost completely reabsorbed in the proximal tubule,
        which provides a quantitative estimation of proximal tubule reabsorption. We hypothesized
        that endogenous lithium reabsorption is impaired in the early stages of critical illness.
  
        We would like to study 10 ICU patients with AKI diagnosed, 10 patients without AKI, and 10
        healthy controls. Blood and urine samples will be obtained at 08:00, 14:00 and 20:00 during
        one day. Renal clearance of creatinine (CCr) and lithium will be calculated.
  observational model: Case-Control
  time perspective: Prospective
  measure: Lithium clearance
  time frame: 2 days
  arm group label: Group 1
  description: ICU patients with AKI
  arm group label: Group 2
  description: ICU patients with normal renal function
  arm group label: Group 3
  description: Healthy controls
  intervention type: Diagnostic Test
  intervention name: Lithium clearance
  description: Blood and urine samples
  arm group label: Group 1
  arm group label: Group 2
  arm group label: Group 3
  Urine and blood
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Lars Marius Ytrebø
  phone: 90788058
  email: lars.marius.ytrebo@unn.no
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Norway
  responsible party type: Sponsor
  mesh term: Acute Kidney Injury
  mesh term: Wounds and Injuries
  mesh term: Lithium Carbonate
  sharing ipd: No