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/NCT06013800</url>
    </required_header>
    <id_info>
      <org_study_id>01-93-254-2023</org_study_id>
      <nct_id>NCT06013800</nct_id>
    </id_info>
    <brief_title>Hyponatremia Volume Status Analysis by Point-of-care Ultrasound</brief_title>
    <acronym>Vostaus</acronym>
    <official_title>Volume Status Analysis by Point-of-care Ultrasound: a Cohort Study in Hyponatremia in Internal Medicine</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universidad Veracruzana</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universidad Veracruzana</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>
        This observational study aims to analyze the time of correction of hyponatremia in patients&#xD;
        within an internal medicine ward. The researchers will assess volume status using both&#xD;
        clinical evaluation and point-of-care ultrasound. Patients will be categorized based on&#xD;
        whether they have the same volume status determined clinically and by ultrasound or a&#xD;
        different status between the two methods. By tracking sodium levels daily until&#xD;
        normalization, the study will compare the time of hyponatremia correction between the two&#xD;
        groups.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The main question it aims to answer are ¿What is the time of correction of hyponatremia by&#xD;
        assessing the volume status clinically or by point of care of ultrasound?.&#xD;
  &#xD;
        Participants will be asked to participate in the study and they will be receive a volume&#xD;
        status by a portable ultrasound. If they have the same volume status clinically and by point&#xD;
        of care ultrasound they will be referred as group 1. If they have a different volume status&#xD;
        clinically or by point of care ultrasound they will be referred as group 2.&#xD;
  &#xD;
        Researchers will follow the patients by measuring the sodium levels daily until they reach&#xD;
        normal sodium levels ( &gt;135mEq/L) and will compare group 1 and group 2 with a survival&#xD;
        analysis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2024</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>Rate of participants with sodium level &gt;135mEq/L</measure>
      <time_frame>Baseline, everyday up to 30 days</time_frame>
      <description>Rate of Achieving a Normal Sodium Level (&gt;135mEq/L) per Participant:&#xD;
  This information will be visually represented through Group 1 and Group 2 using a Kaplan-Meier curve. Subsequently, the data will be evaluated using the Log-Rank test or the Breslow test for statistical significance.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Rate of participants with overcorrection of sodium</measure>
      <time_frame>Baseline, everyday up to 30 days</time_frame>
      <description>This refers to participants who experienced daily corrections greater than 8mEq/L or 18mEq/L in 48 hours.&#xD;
  Rate of Sodium Overcorrection in Group 1 and Group 2 within 30 Days.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All cause mortality</measure>
      <time_frame>Baseline, everyday up to 30 days</time_frame>
      <description>Rate of death of participants in group 1 and group 2 within 30 days</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of stay</measure>
      <time_frame>Baseline, everyday up to 30 days</time_frame>
      <description>Length of index hospital stay in days up to 30 days in group 1 and group 2.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of additional treatment</measure>
      <time_frame>Baseline, everyday up to 48 hours</time_frame>
      <description>Additional treatment is performed if symptom is not relieved or undercorrection develops (achieved Na &lt; 5mmol/L with 24 hours or achieved Na &lt;12mmol/L within 48 hours)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determination of risk factors associated with additional treatment</measure>
      <time_frame>Baseline, everyday up to 48 hours</time_frame>
      <description>Additional treatment is performed if symptom is not relieved or undercorrection develops (achieved Na &lt; 5mmol/L with 24 hours or achieved Na &lt;12mmol/L within 48 hours).&#xD;
  patients who received 3% hypertonic saline and &lt;3% hypertonic saline, patients with ascites due to liver disease, patients with gastrointestinal losses and diuretic use, patients with gastrointestinal losses and chronic kidney disease, patients over 65 years and using antidepressants, patients with active cancer, patients with pneumonia, patients with exacerbation of Chronic Obstructive Pulmonary Disease, patients with sodium levels &lt;125mEq/L, patients with traumatic brain injury and patients with cerebrovascular disease</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Hyponatremia</condition>
    <condition>Water-Electrolyte Imbalance</condition>
    <arm_group>
      <arm_group_label>Same Volume Status (Clinical and Point-of-Care Ultrasound)</arm_group_label>
      <description>The patient has the same volume status clinically and by point-of-care ultrasound</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Different Volume Status (Clinical or Point-of-Care Ultrasound)</arm_group_label>
      <description>The patient has a different volume status clinically or by point-of-care ultrasound</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Measurement of sodium levels</intervention_name>
      <description>Patients will get measurements of sodium levels daily in the first 48 hours, then daily or every other day until normal sodium levels (&gt;135mEq/L).</description>
      <arm_group_label>Different Volume Status (Clinical or Point-of-Care Ultrasound)</arm_group_label>
      <arm_group_label>Same Volume Status (Clinical and Point-of-Care Ultrasound)</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Blood&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with hypotonic hyponatremia&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age greater or equal to 18 years&#xD;
  &#xD;
            -  Hypotonic hyponatremia (less than 275mosm/kg) calculated by the following formula (2&#xD;
               Na+Glucose/ 18)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who are critically ill with ventilatory support.&#xD;
  &#xD;
            -  Patients with clinical signs suggestive of hypovolemia and have a documented history&#xD;
               of aortic insufficiency or show mitral insufficiency during POCUS (Point-of-Care&#xD;
               Ultrasound).&#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>Alejandro Martínez Carreón, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Universidad Veracruzana</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alejandro Martínez Carreón, MD</last_name>
      <phone>+522291611685</phone>
      <email>alejandromtc23@hotmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hospital Regional B Veracruz Alta Especialidad</name>
        <address>
          <city>Veracruz</city>
          <zip>91700</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <contact>
        <last_name>Alejandro Martinez Carreon, MD</last_name>
        <phone>+52 2291611685</phone>
        <email>alejandromtc23@hotmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Mexico</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 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>Universidad Veracruzana</investigator_affiliation>
      <investigator_full_name>Alejandro Martínez Carreón</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>hyponatremia</keyword>
    <keyword>water-electrolyte imbalance</keyword>
    <keyword>POCUS</keyword>
    <keyword>Point-of-care ultrasound</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hyponatremia</mesh_term>
      <mesh_term>Water-Electrolyte Imbalance</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/NCT06013800
  org study id: 01-93-254-2023
  nct id: NCT06013800
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This observational study aims to analyze the time of correction of hyponatremia in patients
        within an internal medicine ward. The researchers will assess volume status using both
        clinical evaluation and point-of-care ultrasound. Patients will be categorized based on
        whether they have the same volume status determined clinically and by ultrasound or a
        different status between the two methods. By tracking sodium levels daily until
        normalization, the study will compare the time of hyponatremia correction between the two
        groups.
  The main question it aims to answer are ¿What is the time of correction of hyponatremia by
        assessing the volume status clinically or by point of care of ultrasound?.
  
        Participants will be asked to participate in the study and they will be receive a volume
        status by a portable ultrasound. If they have the same volume status clinically and by point
        of care ultrasound they will be referred as group 1. If they have a different volume status
        clinically or by point of care ultrasound they will be referred as group 2.
  
        Researchers will follow the patients by measuring the sodium levels daily until they reach
        normal sodium levels ( >135mEq/L) and will compare group 1 and group 2 with a survival
        analysis.
  observational model: Cohort
  time perspective: Prospective
  measure: Rate of participants with sodium level >135mEq/L
  time frame: Baseline, everyday up to 30 days
  description: Rate of Achieving a Normal Sodium Level (>135mEq/L) per Participant:
  This information will be visually represented through Group 1 and Group 2 using a Kaplan-Meier curve. Subsequently, the data will be evaluated using the Log-Rank test or the Breslow test for statistical significance.
  measure: Rate of participants with overcorrection of sodium
  time frame: Baseline, everyday up to 30 days
  description: This refers to participants who experienced daily corrections greater than 8mEq/L or 18mEq/L in 48 hours.
  Rate of Sodium Overcorrection in Group 1 and Group 2 within 30 Days.
  measure: All cause mortality
  time frame: Baseline, everyday up to 30 days
  description: Rate of death of participants in group 1 and group 2 within 30 days
  measure: Length of stay
  time frame: Baseline, everyday up to 30 days
  description: Length of index hospital stay in days up to 30 days in group 1 and group 2.
  measure: Incidence of additional treatment
  time frame: Baseline, everyday up to 48 hours
  description: Additional treatment is performed if symptom is not relieved or undercorrection develops (achieved Na < 5mmol/L with 24 hours or achieved Na <12mmol/L within 48 hours)
  measure: Determination of risk factors associated with additional treatment
  time frame: Baseline, everyday up to 48 hours
  description: Additional treatment is performed if symptom is not relieved or undercorrection develops (achieved Na < 5mmol/L with 24 hours or achieved Na <12mmol/L within 48 hours).
  patients who received 3% hypertonic saline and <3% hypertonic saline, patients with ascites due to liver disease, patients with gastrointestinal losses and diuretic use, patients with gastrointestinal losses and chronic kidney disease, patients over 65 years and using antidepressants, patients with active cancer, patients with pneumonia, patients with exacerbation of Chronic Obstructive Pulmonary Disease, patients with sodium levels <125mEq/L, patients with traumatic brain injury and patients with cerebrovascular disease
  arm group label: Same Volume Status (Clinical and Point-of-Care Ultrasound)
  description: The patient has the same volume status clinically and by point-of-care ultrasound
  arm group label: Different Volume Status (Clinical or Point-of-Care Ultrasound)
  description: The patient has a different volume status clinically or by point-of-care ultrasound
  intervention type: Other
  intervention name: Measurement of sodium levels
  description: Patients will get measurements of sodium levels daily in the first 48 hours, then daily or every other day until normal sodium levels (>135mEq/L).
  arm group label: Different Volume Status (Clinical or Point-of-Care Ultrasound)
  arm group label: Same Volume Status (Clinical and Point-of-Care Ultrasound)
  Blood
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Alejandro Martínez Carreón, MD
  role: Principal Investigator
  affiliation: Universidad Veracruzana
  last name: Alejandro Martínez Carreón, MD
  phone: +522291611685
  email: alejandromtc23@hotmail.com
  facility: 
  contact: 
  country: Mexico
  responsible party type: Principal Investigator
  investigator affiliation: Universidad Veracruzana
  investigator full name: Alejandro Martínez Carreón
  investigator title: Principal Investigator
  mesh term: Hyponatremia
  mesh term: Water-Electrolyte Imbalance