<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/NCT03263598</url>
  </required_header>
  <id_info>
    <org_study_id>random Urine Na/K</org_study_id>
    <nct_id>NCT03263598</nct_id>
  </id_info>
  <brief_title>Validation of Diagnostic Usefulness of the Random Urine Na/K Ratio for Replacement of 24hr Urine Na Excretion in Cirrhotic Patients With Ascites</brief_title>
  <acronym>urine Na/K</acronym>
  <official_title>Clinical Significance and Correlation Between the 24-Hour Urine Sodium Excretion and the Spot Urine Na/K Ratio in Cirrhotic Patients With Ascites.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jang Byoung Kuk</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Yeungnam University College of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kyungpook National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Daegu Catholic University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>DongGuk University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Keimyung University Dongsan Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The low sodium intake is important for ascites control in liver cirrhosis patients.&#xD;
      Therefore, World Health Organization (WHO) recommends reduction of sodium (Na) to 2g/day for&#xD;
      adults. The 24-hour urine Na excretion has been regarded as a standard method to estimate the&#xD;
      amount of daily dietary sodium intake. However, it is too inconvenient to apply to patients&#xD;
      or the general population in practice. For this reason, it has been suggested that a spot&#xD;
      urine Na/potassium (K) ratio could be replaced with the 24-hour urine Na excretion. However,&#xD;
      the evidence is not sufficient for that. The investigators will evaluate the usefulness of&#xD;
      spot urine Na/K ratio to estimate the dietary sodium intake. The investigators will also&#xD;
      verify several formulas of estimating the 24-hour Na excretion with spot urine Na, K,&#xD;
      Creatinine (Cr).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      ● Detailed Description:&#xD;
&#xD;
        1. Measurements: they should be performed for 2 days (the urine collected within 24 hrs)&#xD;
&#xD;
             -  24-hour urine Na, K and Creatinine (patients were instructed to collect all&#xD;
                subsequent urine voids over the next 24-hour period including the ﬁrst void of the&#xD;
                following day.)&#xD;
&#xD;
             -  Spot urine Na, K, Creatinine with the same urine sample in some containers provided&#xD;
                to patients. (every urination)&#xD;
&#xD;
        2. Calculation&#xD;
&#xD;
             -  Na/K Ratio with spot urine Na, K&#xD;
&#xD;
             -  Estimating 24-hour urine Na with spot urine Na, K, Cr by using some formulas.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2016</start_date>
  <completion_date type="Actual">February 2020</completion_date>
  <primary_completion_date type="Actual">February 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>To evaluate the usefulness of urine Na / K ratio as a clinical indicator to replace the 24-hour urine sodium excretion (mEq/L) in liver cirrhosis patients with ascites.</measure>
    <time_frame>After 24 hours of urine collection</time_frame>
    <description>Previous studies have reported that the spot urine Na / K ratio is 90 percent accuracy compared to 24hr urine Na excretion. To verify this, measure spot urine Na, K (mEq/L) by using the same sample as the 24-hour sodium and creatinine excretion and confirm with receiver operator characteristic (ROC) curve to find the best cutoff point of spot urine Na / K ratio.</description>
  </primary_outcome>
  <enrollment type="Actual">195</enrollment>
  <condition>Liver Cirrhosis</condition>
  <condition>Ascites</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Volunteers from the patient population including liver cirrhosis with ascites in&#xD;
        multi-center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Liver cirrhotic patients with ascites diagnosed by imaging study, biopsy or&#xD;
             clinically, regardless of taking diuretics.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled sepsis or systemic infection.&#xD;
&#xD;
          -  Serum Creatinine &gt;1.5 mg/dL.&#xD;
&#xD;
          -  Patients who are being treated for cancers except hepatocellular carcinoma.&#xD;
&#xD;
          -  Patients who refuse the examine or are not cooperative.&#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>Jang Byoung Kuk</name>
      <address>
        <city>Daegu</city>
        <state>Kyoungpuk</state>
        <zip>410-773</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 18, 2016</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>February 20, 2020</last_update_submitted>
  <last_update_submitted_qc>February 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Keimyung University Dongsan Medical Center</investigator_affiliation>
    <investigator_full_name>Jang Byoung Kuk</investigator_full_name>
    <investigator_title>Keimyung University Dongsan medical center</investigator_title>
  </responsible_party>
  <keyword>liver cirrhosis</keyword>
  <keyword>ascites</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
    <mesh_term>Ascites</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03263598
org study id: random Urine Na/K
nct id: NCT03263598
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The low sodium intake is important for ascites control in liver cirrhosis patients.
      Therefore, World Health Organization (WHO) recommends reduction of sodium (Na) to 2g/day for
      adults. The 24-hour urine Na excretion has been regarded as a standard method to estimate the
      amount of daily dietary sodium intake. However, it is too inconvenient to apply to patients
      or the general population in practice. For this reason, it has been suggested that a spot
      urine Na/potassium (K) ratio could be replaced with the 24-hour urine Na excretion. However,
      the evidence is not sufficient for that. The investigators will evaluate the usefulness of
      spot urine Na/K ratio to estimate the dietary sodium intake. The investigators will also
      verify several formulas of estimating the 24-hour Na excretion with spot urine Na, K,
      Creatinine (Cr).
● Detailed Description:

        1. Measurements: they should be performed for 2 days (the urine collected within 24 hrs)

             -  24-hour urine Na, K and Creatinine (patients were instructed to collect all
                subsequent urine voids over the next 24-hour period including the ﬁrst void of the
                following day.)

             -  Spot urine Na, K, Creatinine with the same urine sample in some containers provided
                to patients. (every urination)

        2. Calculation

             -  Na/K Ratio with spot urine Na, K

             -  Estimating 24-hour urine Na with spot urine Na, K, Cr by using some formulas.
observational model: Cohort
time perspective: Prospective
measure: To evaluate the usefulness of urine Na / K ratio as a clinical indicator to replace the 24-hour urine sodium excretion (mEq/L) in liver cirrhosis patients with ascites.
time frame: After 24 hours of urine collection
description: Previous studies have reported that the spot urine Na / K ratio is 90 percent accuracy compared to 24hr urine Na excretion. To verify this, measure spot urine Na, K (mEq/L) by using the same sample as the 24-hour sodium and creatinine excretion and confirm with receiver operator characteristic (ROC) curve to find the best cutoff point of spot urine Na / K ratio.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: Keimyung University Dongsan Medical Center
investigator full name: Jang Byoung Kuk
investigator title: Keimyung University Dongsan medical center
mesh term: Liver Cirrhosis
mesh term: Fibrosis
mesh term: Ascites
sharing ipd: Undecided