<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/NCT02212093</url>
  </required_header>
  <id_info>
    <org_study_id>2013/2338</org_study_id>
    <nct_id>NCT02212093</nct_id>
  </id_info>
  <brief_title>5 Years Mortality-rate in Patients Treated for Severe Pneumonia in an ICU - a Retrospective Study</brief_title>
  <acronym>pneumonia</acronym>
  <official_title>Cause-specific 5 Years Mortality-rate in Patients Treated for Severe Pneumonia in an ICU - a Retrospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Akershus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Akershus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Severe pneumonia has a high in-hospital mortality. There are few studies which investigate&#xD;
      the long-term mortality in patients that are discharged alive from the hospital. In this&#xD;
      study we want to investigate the 5 years mortality after treatment of severe pneumonia in an&#xD;
      ICU. We will also investigate the cause of death after discharge from the hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with severe pneumonia who need treatment in an ICU have a high in-hospital mortality&#xD;
      (16-46%). There are few studies which investigate the long-term mortality (&gt; 1year) in&#xD;
      patients after discharge from the hospital. There seems to be a higher mortality in this&#xD;
      group compared to the general population. The cause(s) of this higher long-term mortality is&#xD;
      unclear and few studies have investigated this problem.&#xD;
&#xD;
      We are going to investigate the 5 years mortality rate in this population of patients. We are&#xD;
      also going to investigate the cause of death in the patients who are discharged from the&#xD;
      hospital alive.&#xD;
&#xD;
      Inclusion criteria: Patients &gt; 18 years. Primary diagnose: pneumonia, and the need of&#xD;
      mechanical ventilation for at least 24 hours in an ICU. The patients who arrive at the ICU in&#xD;
      Akershus University Hospital in the period from 01.01.1997 to 31.12.2006.&#xD;
&#xD;
      The datas are collected from the patients' journals and the local ICU register. Collecting&#xD;
      data: Age, sex, comorbidity, SAPSII, mechanical ventilation time, stay in the ICU, stay in&#xD;
      the hospital, ICU mortality, hospital mortality, 5 years mortality, type of pneumonia&#xD;
      (bacteriology).&#xD;
&#xD;
      Time of death after discharge is collected from Norwegian National Registry. Cause of death&#xD;
      after discharge is collected from Norwegian Institute of Public Health.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>5 years mortality</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>cause of death after discharge from the hospital</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">236</enrollment>
  <condition>Pneumonia</condition>
  <arm_group>
    <arm_group_label>pneumonia and mechanical ventilation</arm_group_label>
    <description>The data are collected retrospectively from this one group.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Bacteriology tests&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The same as the inclusion criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients &gt; 18 years. Primary diagnose: pneumonia, and the need of mechanical&#xD;
             ventilation for at least 24 hours in an ICU. The patients who arrived the ICU in&#xD;
             Akershus University Hospital in the period from 01.01.1997 to 31.12.2006.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients &lt; 18 years. Patients with need for mechanical ventilation &lt; 24 hours&#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>Vegard Dahl, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Akershus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Akershus University Hospital</name>
      <address>
        <city>Nordbyhagen</city>
        <state>Akershus</state>
        <zip>1478</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>July 22, 2015</last_update_submitted>
  <last_update_submitted_qc>July 22, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 23, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Akershus</investigator_affiliation>
    <investigator_full_name>Vegard Dahl</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Pneumonia, mechanical ventilation, ICU, mortality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
  </condition_browse>
  <!-- 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/NCT02212093
org study id: 2013/2338
nct id: NCT02212093
lead sponsor: 
collaborator: 
has dmc: No
Severe pneumonia has a high in-hospital mortality. There are few studies which investigate
      the long-term mortality in patients that are discharged alive from the hospital. In this
      study we want to investigate the 5 years mortality after treatment of severe pneumonia in an
      ICU. We will also investigate the cause of death after discharge from the hospital.
Patients with severe pneumonia who need treatment in an ICU have a high in-hospital mortality
      (16-46%). There are few studies which investigate the long-term mortality (> 1year) in
      patients after discharge from the hospital. There seems to be a higher mortality in this
      group compared to the general population. The cause(s) of this higher long-term mortality is
      unclear and few studies have investigated this problem.

      We are going to investigate the 5 years mortality rate in this population of patients. We are
      also going to investigate the cause of death in the patients who are discharged from the
      hospital alive.

      Inclusion criteria: Patients > 18 years. Primary diagnose: pneumonia, and the need of
      mechanical ventilation for at least 24 hours in an ICU. The patients who arrive at the ICU in
      Akershus University Hospital in the period from 01.01.1997 to 31.12.2006.

      The datas are collected from the patients' journals and the local ICU register. Collecting
      data: Age, sex, comorbidity, SAPSII, mechanical ventilation time, stay in the ICU, stay in
      the hospital, ICU mortality, hospital mortality, 5 years mortality, type of pneumonia
      (bacteriology).

      Time of death after discharge is collected from Norwegian National Registry. Cause of death
      after discharge is collected from Norwegian Institute of Public Health.
time perspective: Retrospective
measure: 5 years mortality
time frame: 5 years
measure: cause of death after discharge from the hospital
time frame: 5 years
arm group label: pneumonia and mechanical ventilation
description: The data are collected retrospectively from this one group.
Bacteriology tests
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vegard Dahl, Professor
role: Principal Investigator
affiliation: University Hospital, Akershus
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Akershus
investigator full name: Vegard Dahl
investigator title: Professor
mesh term: Pneumonia