<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/NCT03835169</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL18_0429</org_study_id>
    <nct_id>NCT03835169</nct_id>
  </id_info>
  <brief_title>Intra Hospital Mortality Risk Factors in Patients Admitted to Cardiac Intensive Care Units in 2017 in France</brief_title>
  <acronym>USIC -BNAT</acronym>
  <official_title>Intra Hospital Mortality Risk Factors in Patients Admitted to Cardiac Intensive Care Units in 2017 in France: A Nationwide Retrospective Observational Cohort Study Using Data From the French Hospital Discharge Database</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</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>
      Retrospective, observational cohort study.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      To identify intra hospital mortality risk factors in patients admitted admitted to cardiac&#xD;
      intensive care units (CICU). The clinical main endpoint will be the observed percentage of&#xD;
      deaths that occured during the year 2017 in french CICU.&#xD;
&#xD;
      To identify the length of stay key determiners of patients admitted in french CICU.&#xD;
&#xD;
      The study will use data from one of the french nationwide healthcare systems database (SNDS)&#xD;
      : the national hospital discharge database (PMSI) to be precise.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 24, 2019</start_date>
  <completion_date type="Actual">December 30, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality rate</measure>
    <time_frame>1 day</time_frame>
    <description>Observed percentage of deaths that occured during the year 2017 in french CICU</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of stay at a CICU</measure>
    <time_frame>1 year</time_frame>
    <description>Length of stay at a CICU</description>
  </secondary_outcome>
  <enrollment type="Actual">200000</enrollment>
  <condition>Heart Disease</condition>
  <condition>Acute Coronary Syndrome</condition>
  <condition>Acute Cardiac Failure</condition>
  <condition>Heart Rhythm Disorders</condition>
  <condition>Valve Pathologies</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted (at least one time) in a french CICU in 2017&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Being admitted at least one time in a french CICU in 2017&#xD;
&#xD;
          -  Being covered by the mandatory french national health insurance plan in 2017 without&#xD;
             discontinuity&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Being older than 18 years of age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>François Roubille, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uhmontpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>August 10, 2022</last_update_submitted>
  <last_update_submitted_qc>August 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cardiac intensive care unit</keyword>
  <keyword>Organization</keyword>
  <keyword>Prognostic score</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>NC</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/NCT03835169
org study id: RECHMPL18_0429
nct id: NCT03835169
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Retrospective, observational cohort study.

      Objectives:

      To identify intra hospital mortality risk factors in patients admitted admitted to cardiac
      intensive care units (CICU). The clinical main endpoint will be the observed percentage of
      deaths that occured during the year 2017 in french CICU.

      To identify the length of stay key determiners of patients admitted in french CICU.

      The study will use data from one of the french nationwide healthcare systems database (SNDS)
      : the national hospital discharge database (PMSI) to be precise.
observational model: Cohort
time perspective: Retrospective
measure: Mortality rate
time frame: 1 day
description: Observed percentage of deaths that occured during the year 2017 in french CICU
measure: Length of stay at a CICU
time frame: 1 year
description: Length of stay at a CICU
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: François Roubille, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Acute Coronary Syndrome
mesh term: Heart Failure
mesh term: Arrhythmias, Cardiac
sharing ipd: Undecided
ipd description: NC