<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/NCT04493268</url>
  </required_header>
  <id_info>
    <org_study_id>HYPONATREMIA IN COVID PATIENTS</org_study_id>
    <nct_id>NCT04493268</nct_id>
  </id_info>
  <brief_title>HYPONATREMIA IN COVID-19 PATIENTS</brief_title>
  <official_title>HYPONATREMIA AND INFLAMMATION AND CLINICAL OUTCOMES IN HOSPITALIZED COVID-19 PATIENTS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Nacional Profesor Alejandro Posadas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Nacional Profesor Alejandro Posadas</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>
      SYSTEMIC INFLAMMATION HAS BEEN ASSOCIATED WITH SEVERE COVID-19. HYPONATREMIA CAN RESULT FROM&#xD;
      INFLAMMATION DUE TO NON-OSMOTIC STIMULI FOR VASOPRESSIN PRODUCTION. IN THIS PROSPECTIVE&#xD;
      COHORT STUDY WE ANALIZED DATA FROM PATIENTS WITH COVID-19 AND THE ASOCIATION WITH&#xD;
      HYPONATREMIA AND CLINICAL OUTCOMES.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 7, 2020</start_date>
  <completion_date type="Actual">July 21, 2020</completion_date>
  <primary_completion_date type="Actual">July 20, 2020</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>MORTALITY</measure>
    <time_frame>30 DAYS</time_frame>
    <description>HYPONATREMIA AND MORTALITY</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ICU HOSPITALIZATION</measure>
    <time_frame>30 DAYS</time_frame>
    <description>HYPONATREMIA AND ICU HOSPITALIZATION</description>
  </secondary_outcome>
  <enrollment type="Actual">250</enrollment>
  <condition>Hyponatremia</condition>
  <condition>Covid19</condition>
  <condition>Corona Virus Infection</condition>
  <eligibility>
    <study_pop>
      <textblock>
        GENERAL POPULATION&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PATIENTS WITH SARS-CoV-2 INFECTION CONFIRMED BY PCR OF NASOPHARYNGEAL SWABS.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>100 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>CARLOS EGHI, physician</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Buenos Aires</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Posadas</name>
      <address>
        <city>Buenos Aires</city>
        <zip>1684</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Nacional Profesor Alejandro Posadas</investigator_affiliation>
    <investigator_full_name>Ladislao Diaz Ballve</investigator_full_name>
    <investigator_title>GRADUATE IN KINESIOLOGY</investigator_title>
  </responsible_party>
  <keyword>INFLAMMATION</keyword>
  <keyword>COVID</keyword>
  <keyword>CORONA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
    <mesh_term>Hyponatremia</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/NCT04493268
org study id: HYPONATREMIA IN COVID PATIENTS
nct id: NCT04493268
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
SYSTEMIC INFLAMMATION HAS BEEN ASSOCIATED WITH SEVERE COVID-19. HYPONATREMIA CAN RESULT FROM
      INFLAMMATION DUE TO NON-OSMOTIC STIMULI FOR VASOPRESSIN PRODUCTION. IN THIS PROSPECTIVE
      COHORT STUDY WE ANALIZED DATA FROM PATIENTS WITH COVID-19 AND THE ASOCIATION WITH
      HYPONATREMIA AND CLINICAL OUTCOMES.
observational model: Cohort
time perspective: Prospective
measure: MORTALITY
time frame: 30 DAYS
description: HYPONATREMIA AND MORTALITY
measure: ICU HOSPITALIZATION
time frame: 30 DAYS
description: HYPONATREMIA AND ICU HOSPITALIZATION
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 100 Years
last name: CARLOS EGHI, physician
role: Principal Investigator
affiliation: University of Buenos Aires
facility: 
country: Argentina
responsible party type: Principal Investigator
investigator affiliation: Hospital Nacional Profesor Alejandro Posadas
investigator full name: Ladislao Diaz Ballve
investigator title: GRADUATE IN KINESIOLOGY
mesh term: COVID-19
mesh term: Coronavirus Infections
mesh term: Hyponatremia
sharing ipd: Undecided