<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/NCT04409626</url>
  </required_header>
  <id_info>
    <org_study_id>REG-2020-05-05</org_study_id>
    <nct_id>NCT04409626</nct_id>
  </id_info>
  <brief_title>Hyponatraemia and Mortality in Schizophrenic and Bipolar Patients: Protocol for a Bayesian Causal Inference Study</brief_title>
  <official_title>Is Hyponatraemia a Risk Factor for Mortality in Schizophrenic and Bipolar Patients? Protocol for a Bayesian Causal Inference Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zealand University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zealand University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study seeks to investigate if hyponatraemia be a direct contributor to death in&#xD;
      schizophrenic and bipolar patients, and gauge the potential role of somatic comorbidity and&#xD;
      psychotropic polypharmacy, with emphasis on antipsychotics and antidepressants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 1, 2011</start_date>
  <completion_date type="Anticipated">August 2020</completion_date>
  <primary_completion_date type="Anticipated">July 2020</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>Mortality</measure>
    <time_frame>1 January 2011 through 1 July 2016</time_frame>
    <description>All-cause mortality</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">31740</enrollment>
  <condition>Hyponatremia</condition>
  <condition>SIADH</condition>
  <arm_group>
    <arm_group_label>Cases</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>Matched (5 controls per case) by date of birth +/- 180 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Plasma sodium level (continuous variables)</intervention_name>
    <description>Observational study, so the exposures of interest (5-year mean and minimum plasma sodium) are not administered to the patients. Ultimately, our interest is in hyponatraemia.</description>
    <arm_group_label>Cases</arm_group_label>
    <arm_group_label>Controls</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Cases:&#xD;
&#xD;
          -  Died in our catchment area between 1 January 2011 and 1 July 2016.&#xD;
&#xD;
        Controls:&#xD;
&#xD;
          -  5 controls per case found by risk-set sampling with replacement, matched on date of&#xD;
             birth +/- 180 days.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Source population:&#xD;
&#xD;
          -  Danish residents&#xD;
&#xD;
          -  At least one International Classification of Diseases version 10 (ICD-10) F2 or F31&#xD;
             diagnosis from a hospital in Region Zealand and the Capital Region (Denmark)&#xD;
&#xD;
        No exclusion criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Causality</keyword>
  <keyword>Bayesian analysis</keyword>
  <keyword>Antipsychotics</keyword>
  <keyword>Psychotropics</keyword>
  <keyword>Polypharmacy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyponatremia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We are unfortunately unable to share individual participant data, as our data source comprises sensitive information from electronic medical records and national registries.</ipd_description>
  </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/NCT04409626
org study id: REG-2020-05-05
nct id: NCT04409626
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study seeks to investigate if hyponatraemia be a direct contributor to death in
      schizophrenic and bipolar patients, and gauge the potential role of somatic comorbidity and
      psychotropic polypharmacy, with emphasis on antipsychotics and antidepressants.
observational model: Case-Control
time perspective: Prospective
measure: Mortality
time frame: 1 January 2011 through 1 July 2016
description: All-cause mortality
arm group label: Cases
arm group label: Controls
description: Matched (5 controls per case) by date of birth +/- 180 days.
intervention type: Other
intervention name: Plasma sodium level (continuous variables)
description: Observational study, so the exposures of interest (5-year mean and minimum plasma sodium) are not administered to the patients. Ultimately, our interest is in hyponatraemia.
arm group label: Cases
arm group label: Controls
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Hyponatremia
sharing ipd: No
ipd description: We are unfortunately unable to share individual participant data, as our data source comprises sensitive information from electronic medical records and national registries.