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/NCT06037928</url>
    </required_header>
    <id_info>
      <org_study_id>IVA-salt</org_study_id>
      <nct_id>NCT06037928</nct_id>
    </id_info>
    <brief_title>Plasma Sodium and Sodium Administration in the ICU</brief_title>
    <official_title>Plasma Sodium and Sodium Administration in the ICU. A Retrospective Observational Study.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Linkoeping</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Linkoeping</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>
        Background: Patients in the Intensive Care Unit often present with low levels of plasma&#xD;
        sodium and are therefore often administered high amounts of sodium, both as an additive to&#xD;
        intravenous glucose solutions and as a constituent of various drugs and infusion fluids.&#xD;
        Recent findings question the benefit of these large quantities of sodium and raise the&#xD;
        question whether the individual physician takes the total sodium administration into account&#xD;
        when sodium additives are prescribed. It can also be suspected that sodium prescription&#xD;
        differs significantly between physicians.&#xD;
  &#xD;
        Primary research question:&#xD;
  &#xD;
        • Is there a correlation between prescribed sodium additive and the expected amount of sodium&#xD;
        the patient receives through other routes?&#xD;
  &#xD;
        Secondary research questions:&#xD;
  &#xD;
          1. Is the prescribing physician a significant factor for variation in the amount of&#xD;
             prescribed sodium additive?&#xD;
  &#xD;
          2. Do anesthesiologists mainly working in intensive care administer more sodium than other&#xD;
             anesthesiologists?&#xD;
  &#xD;
          3. Is there a difference between older and younger anesthesiologists concerning the amount&#xD;
             of prescribed sodium as an additive?&#xD;
  &#xD;
          4. Is the amount of added sodium adjusted to the severity of hyponatremia?&#xD;
  &#xD;
          5. Is there a correlation between prescribed sodium additive and observed changes in plasma&#xD;
             sodium?&#xD;
  &#xD;
          6. Is there a correlation between the total amount of administered sodium and observed&#xD;
             changes in plasma sodium?&#xD;
  &#xD;
        Study design: Retrospective observational study&#xD;
  &#xD;
        Study population: Intensive Care Unit-patients at the Central Intensive Care Unit (CIVA) in&#xD;
        Linköping University Hospital&#xD;
  &#xD;
        Number of participants: 200&#xD;
  &#xD;
        Inclusion criteria:&#xD;
  &#xD;
          -  Adult&#xD;
  &#xD;
          -  Documented length of stay at the Central Intensive Care Unit (CIVA) at the University&#xD;
             Hospital of Linköping of seven (7) days minimum.&#xD;
  &#xD;
          -  The patient has been discharged from the ICU.&#xD;
  &#xD;
          -  Body Mass Index (BMI) between 18.0 and 48.0 kg/m2 at admission.&#xD;
  &#xD;
        Exclusion criteria:&#xD;
  &#xD;
          -  The patient has previously been included in the study in connection with another&#xD;
             ICU-admission.&#xD;
  &#xD;
          -  The patient has a severe hyponatremia (&lt;129 mmol/L) upon arrival to the ICU.&#xD;
  &#xD;
          -  The patient has a severe hypernatremia (&gt;149 mmol/L) upon arrival to the ICU.&#xD;
  &#xD;
          -  The patient is severely hyperosmolar (&gt;330 mmol/L) upon arrival to the ICU.&#xD;
  &#xD;
          -  The patient is severely hyperglycemic (&gt;30 mmol/L) upon arrival to the ICU.&#xD;
  &#xD;
          -  The patient has an elevated serum urea (&gt;30 mmol/L) upon arrival to the ICU.&#xD;
  &#xD;
          -  The patient receives any dialysis treatment during the observation time.&#xD;
  &#xD;
          -  The patient is suspected to have an elevated intracranial pressure during the&#xD;
             observation time or is suspected to have other intracranial pathology that is likely to&#xD;
             affect sodium homeostasis&#xD;
  &#xD;
          -  The patient has an intoxication with toxic alcohols as a primary diagnosis.&#xD;
  &#xD;
        Determination of effect&#xD;
  &#xD;
        Primary outcome measure:&#xD;
  &#xD;
        • The coefficient of determination (r2) between the amount of prescribed sodium additive and&#xD;
        the amount of sodium the patient is expected to receive through other routes.&#xD;
  &#xD;
        Secondary outcome measures:&#xD;
  &#xD;
          1. The coefficient of determination (r2) in a multivariate analysis where prescribing&#xD;
             physician is the independent variable and the amount of prescribed sodium additive is&#xD;
             the dependent variable.&#xD;
  &#xD;
          2. Difference in median or mean in the amount of prescribed sodium additive between&#xD;
             anesthesiologists mainly working in intensive care, anesthesiologists mainly working&#xD;
             with patients undergoing surgery and between resident physicians.&#xD;
  &#xD;
          3. Difference in median or mean in the amount of prescribed sodium additive between&#xD;
             physicians born no later than 12-31-1982 and physicians born 1983 and later.&#xD;
  &#xD;
          4. The coefficient of determination (r2) between plasma sodium and the amount of prescribed&#xD;
             sodium additive.&#xD;
  &#xD;
          5. The coefficient of determination (r2) between the amount of prescribed sodium additive&#xD;
             and observed changes in plasma sodium.&#xD;
  &#xD;
          6. The coefficient of determination (r2) between the total amount of administered sodium&#xD;
             and observed changes in plasma sodium.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 4, 2023</start_date>
    <completion_date type="Anticipated">January 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The coefficient of determination (r2) between the amount prescribed sodium additive and the amount of sodium the patient is expected to receive through other administrations.</measure>
      <time_frame>During admission to ICU for a maximum of 28 days</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>The coefficient of determination (r2) in a multivariate analysis where prescribing physician is the independent variable and the amount of prescribed sodium additive is the dependent variable.</measure>
      <time_frame>During admission to ICU for a maximum of 28 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference in median or mean in the amount of prescribed sodium additive between anesthesiologists mainly working in intensive care, anesthesiologists mainly working with patients undergoing surgery and between resident physicians.</measure>
      <time_frame>During admission to ICU for a maximum of 28 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference in median or mean in the amount of prescribed sodium additive between physicians born no later than 12-31-1982 and physicians born 1983 and later.</measure>
      <time_frame>During admission to ICU for a maximum of 28 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The coefficient of determination (r2) between plasma sodium and the amount of prescribed sodium additive.</measure>
      <time_frame>During admission to ICU for a maximum of 28 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The coefficient of determination (r2) between the amount of prescribed sodium additive and observed changes in plasma sodium.</measure>
      <time_frame>During admission to ICU for a maximum of 28 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The coefficient of determination (r2) between the total amount of administered sodium and observed changes in plasma sodium.</measure>
      <time_frame>During admission to ICU for a maximum of 28 days</time_frame>
    </secondary_outcome>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Hypernatremia</condition>
    <condition>Hyponatremia</condition>
    <condition>Critical Illness</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Critically ill patients with a documented length of stay at the Intensive Care Unit of&#xD;
          seven days minimum&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult&#xD;
  &#xD;
            -  Documented length of stay at the Central Intensive Care Unit (CIVA) at the University&#xD;
               Hospital of Linköping of seven (7) days minimum.&#xD;
  &#xD;
            -  The patient has been discharged from the ICU.&#xD;
  &#xD;
            -  Body Mass Index (BMI) between 18.0 and 48.0 kg/m2 at admission.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The patient has previously been included in the study in connection with another&#xD;
               ICU-admission.&#xD;
  &#xD;
            -  The patient has a severe hyponatremia (&lt;129 mmol/L) upon arrival to the ICU.&#xD;
  &#xD;
            -  The patient has a severe hypernatremia (&gt;149 mmol/L) upon arrival to the ICU.&#xD;
  &#xD;
            -  The patient is severely hyperosmolar (&gt;330 mmol/L) upon arrival to the ICU.&#xD;
  &#xD;
            -  The patient is severely hyperglycemic (&gt;30 mmol/L) upon arrival to the ICU.&#xD;
  &#xD;
            -  The patient has an elevated serum urea (&gt;30 mmol/L) upon arrival to the ICU.&#xD;
  &#xD;
            -  The patient receives any dialysis treatment during the observation time.&#xD;
  &#xD;
            -  The patient is suspected to have an elevated intracranial pressure during the&#xD;
               observation time or is suspected to have other intracranial pathology that is likely&#xD;
               to affect sodium homeostasis&#xD;
  &#xD;
            -  The patient has an intoxication with toxic alcohols as a primary diagnosis.&#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_contact>
      <last_name>Hans Bahlmann, MD, PhD</last_name>
      <phone>+46739312281</phone>
      <email>hans.bahlmann@regionostergotland.se</email>
    </overall_contact>
    <location>
      <facility>
        <name>University Hospital Linköping</name>
        <address>
          <city>Linköping</city>
          <zip>58185</zip>
          <country>Sweden</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Joel Landström</last_name>
        <phone>+46725165345</phone>
        <email>joela037@student.liu.se</email>
      </contact>
    </location>
    <location_countries>
      <country>Sweden</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University Hospital, Linkoeping</investigator_affiliation>
      <investigator_full_name>Hans Bahlmann</investigator_full_name>
      <investigator_title>PhD, senior consultant</investigator_title>
    </responsible_party>
    <keyword>Fluid Therapy</keyword>
    <keyword>ICU</keyword>
    <keyword>Drug Prescription</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hyponatremia</mesh_term>
      <mesh_term>Hypernatremia</mesh_term>
      <mesh_term>Critical Illness</mesh_term>
    </condition_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/NCT06037928
  org study id: IVA-salt
  nct id: NCT06037928
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Background: Patients in the Intensive Care Unit often present with low levels of plasma
        sodium and are therefore often administered high amounts of sodium, both as an additive to
        intravenous glucose solutions and as a constituent of various drugs and infusion fluids.
        Recent findings question the benefit of these large quantities of sodium and raise the
        question whether the individual physician takes the total sodium administration into account
        when sodium additives are prescribed. It can also be suspected that sodium prescription
        differs significantly between physicians.
  
        Primary research question:
  
        • Is there a correlation between prescribed sodium additive and the expected amount of sodium
        the patient receives through other routes?
  
        Secondary research questions:
  
          1. Is the prescribing physician a significant factor for variation in the amount of
             prescribed sodium additive?
  
          2. Do anesthesiologists mainly working in intensive care administer more sodium than other
             anesthesiologists?
  
          3. Is there a difference between older and younger anesthesiologists concerning the amount
             of prescribed sodium as an additive?
  
          4. Is the amount of added sodium adjusted to the severity of hyponatremia?
  
          5. Is there a correlation between prescribed sodium additive and observed changes in plasma
             sodium?
  
          6. Is there a correlation between the total amount of administered sodium and observed
             changes in plasma sodium?
  
        Study design: Retrospective observational study
  
        Study population: Intensive Care Unit-patients at the Central Intensive Care Unit (CIVA) in
        Linköping University Hospital
  
        Number of participants: 200
  
        Inclusion criteria:
  
          -  Adult
  
          -  Documented length of stay at the Central Intensive Care Unit (CIVA) at the University
             Hospital of Linköping of seven (7) days minimum.
  
          -  The patient has been discharged from the ICU.
  
          -  Body Mass Index (BMI) between 18.0 and 48.0 kg/m2 at admission.
  
        Exclusion criteria:
  
          -  The patient has previously been included in the study in connection with another
             ICU-admission.
  
          -  The patient has a severe hyponatremia (<129 mmol/L) upon arrival to the ICU.
  
          -  The patient has a severe hypernatremia (>149 mmol/L) upon arrival to the ICU.
  
          -  The patient is severely hyperosmolar (>330 mmol/L) upon arrival to the ICU.
  
          -  The patient is severely hyperglycemic (>30 mmol/L) upon arrival to the ICU.
  
          -  The patient has an elevated serum urea (>30 mmol/L) upon arrival to the ICU.
  
          -  The patient receives any dialysis treatment during the observation time.
  
          -  The patient is suspected to have an elevated intracranial pressure during the
             observation time or is suspected to have other intracranial pathology that is likely to
             affect sodium homeostasis
  
          -  The patient has an intoxication with toxic alcohols as a primary diagnosis.
  
        Determination of effect
  
        Primary outcome measure:
  
        • The coefficient of determination (r2) between the amount of prescribed sodium additive and
        the amount of sodium the patient is expected to receive through other routes.
  
        Secondary outcome measures:
  
          1. The coefficient of determination (r2) in a multivariate analysis where prescribing
             physician is the independent variable and the amount of prescribed sodium additive is
             the dependent variable.
  
          2. Difference in median or mean in the amount of prescribed sodium additive between
             anesthesiologists mainly working in intensive care, anesthesiologists mainly working
             with patients undergoing surgery and between resident physicians.
  
          3. Difference in median or mean in the amount of prescribed sodium additive between
             physicians born no later than 12-31-1982 and physicians born 1983 and later.
  
          4. The coefficient of determination (r2) between plasma sodium and the amount of prescribed
             sodium additive.
  
          5. The coefficient of determination (r2) between the amount of prescribed sodium additive
             and observed changes in plasma sodium.
  
          6. The coefficient of determination (r2) between the total amount of administered sodium
             and observed changes in plasma sodium.
  observational model: Case-Only
  time perspective: Retrospective
  measure: The coefficient of determination (r2) between the amount prescribed sodium additive and the amount of sodium the patient is expected to receive through other administrations.
  time frame: During admission to ICU for a maximum of 28 days
  measure: The coefficient of determination (r2) in a multivariate analysis where prescribing physician is the independent variable and the amount of prescribed sodium additive is the dependent variable.
  time frame: During admission to ICU for a maximum of 28 days
  measure: Difference in median or mean in the amount of prescribed sodium additive between anesthesiologists mainly working in intensive care, anesthesiologists mainly working with patients undergoing surgery and between resident physicians.
  time frame: During admission to ICU for a maximum of 28 days
  measure: Difference in median or mean in the amount of prescribed sodium additive between physicians born no later than 12-31-1982 and physicians born 1983 and later.
  time frame: During admission to ICU for a maximum of 28 days
  measure: The coefficient of determination (r2) between plasma sodium and the amount of prescribed sodium additive.
  time frame: During admission to ICU for a maximum of 28 days
  measure: The coefficient of determination (r2) between the amount of prescribed sodium additive and observed changes in plasma sodium.
  time frame: During admission to ICU for a maximum of 28 days
  measure: The coefficient of determination (r2) between the total amount of administered sodium and observed changes in plasma sodium.
  time frame: During admission to ICU for a maximum of 28 days
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Hans Bahlmann, MD, PhD
  phone: +46739312281
  email: hans.bahlmann@regionostergotland.se
  facility: 
  status: Recruiting
  contact: 
  country: Sweden
  responsible party type: Principal Investigator
  investigator affiliation: University Hospital, Linkoeping
  investigator full name: Hans Bahlmann
  investigator title: PhD, senior consultant
  mesh term: Hyponatremia
  mesh term: Hypernatremia
  mesh term: Critical Illness
  sharing ipd: No