<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/NCT02972775</url>
  </required_header>
  <id_info>
    <org_study_id>16N164</org_study_id>
    <nct_id>NCT02972775</nct_id>
  </id_info>
  <brief_title>15-year Mortality After Hospitalization for Exacerbation of Chronic Obstructive Pulmonary Disease</brief_title>
  <acronym>MORTCOP</acronym>
  <official_title>15-year Mortality After Hospitalization for Exacerbation of Chronic Obstructive Pulmonary Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zuyderland Medisch Centrum</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zuyderland Medisch Centrum</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators examine the 15-year mortality after an admission for an exacerbation of&#xD;
      Chronic Obstructive Pulmonary disease (COPD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Several prognostic factors will be examined. Cause of death will be examined. Data will be&#xD;
      recruited from medical records and calling general practitioners to find out if a patient is&#xD;
      still alive. Statistical analysis will be done with Kaplan Meier, Cox proportional hazards&#xD;
      and Chi square&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2005</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">October 2017</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>Percentage of patients that died after 15 years</measure>
    <time_frame>15 years</time_frame>
    <description>Mortality after 15 years</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prognostic factors for mortality</measure>
    <time_frame>15 years</time_frame>
    <description>Age (years), Gender (M / F), Previous hospitalization in the past year (yes/no), Re-admission in the next 5 years (number of readmissions per year), forced expiratory volume in 1 second (in liter), Hypercapnia (carbon dioxide in arterial blood in stable condition above 5.9 kiloPascal (kPa) or not), TLCO (transfusion capacity of the lung for carbon monoxide in percentage of predicted, ml / min / kPa), Comorbidity (Charlson Comorbidity Index) Date and cause of death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cause of death</measure>
    <time_frame>15 years</time_frame>
    <description>Chronic obstructive pulmonary disease, lung carcinoma, cardiovascular, other</description>
  </secondary_outcome>
  <enrollment type="Actual">845</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <condition>Exacerbation Copd</condition>
  <condition>Mortality</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no interventions. observational study</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted with an exacerbation of Chronic obstructive pulmonary disease in the&#xD;
        Zuyderland medical Centre from 1996 - 1999&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  admission with exacerbation of COPD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martijn de Kruif, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zuyderland Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zuyderland Medical Center</name>
      <address>
        <city>Heerlen</city>
        <state>Limburg</state>
        <zip>6419 PC</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <reference>
    <citation>Vestbo J, Hurd SS, Agusti AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65. doi: 10.1164/rccm.201204-0596PP. Epub 2012 Aug 9.</citation>
    <PMID>22878278</PMID>
  </reference>
  <reference>
    <citation>Traver GA, Cline MG, Burrows B. Predictors of mortality in chronic obstructive pulmonary disease. A 15-year follow-up study. Am Rev Respir Dis. 1979 Jun;119(6):895-902. doi: 10.1164/arrd.1979.119.6.895.</citation>
    <PMID>453709</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>October 24, 2016</study_first_submitted>
  <study_first_submitted_qc>November 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>June 2, 2020</last_update_submitted>
  <last_update_submitted_qc>June 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zuyderland Medisch Centrum</investigator_affiliation>
    <investigator_full_name>Pauline van Hirtum</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02972775
org study id: 16N164
nct id: NCT02972775
lead sponsor: 
has dmc: No
The investigators examine the 15-year mortality after an admission for an exacerbation of
      Chronic Obstructive Pulmonary disease (COPD).
Several prognostic factors will be examined. Cause of death will be examined. Data will be
      recruited from medical records and calling general practitioners to find out if a patient is
      still alive. Statistical analysis will be done with Kaplan Meier, Cox proportional hazards
      and Chi square
observational model: Cohort
time perspective: Retrospective
measure: Percentage of patients that died after 15 years
time frame: 15 years
description: Mortality after 15 years
measure: Prognostic factors for mortality
time frame: 15 years
description: Age (years), Gender (M / F), Previous hospitalization in the past year (yes/no), Re-admission in the next 5 years (number of readmissions per year), forced expiratory volume in 1 second (in liter), Hypercapnia (carbon dioxide in arterial blood in stable condition above 5.9 kiloPascal (kPa) or not), TLCO (transfusion capacity of the lung for carbon monoxide in percentage of predicted, ml / min / kPa), Comorbidity (Charlson Comorbidity Index) Date and cause of death
measure: Cause of death
time frame: 15 years
description: Chronic obstructive pulmonary disease, lung carcinoma, cardiovascular, other
intervention type: Other
intervention name: no interventions. observational study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Martijn de Kruif, MD, PhD
role: Principal Investigator
affiliation: Zuyderland Medical Center
facility: 
country: Netherlands
citation: Vestbo J, Hurd SS, Agusti AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65. doi: 10.1164/rccm.201204-0596PP. Epub 2012 Aug 9.
PMID: 22878278
citation: Traver GA, Cline MG, Burrows B. Predictors of mortality in chronic obstructive pulmonary disease. A 15-year follow-up study. Am Rev Respir Dis. 1979 Jun;119(6):895-902. doi: 10.1164/arrd.1979.119.6.895.
PMID: 453709
responsible party type: Principal Investigator
investigator affiliation: Zuyderland Medisch Centrum
investigator full name: Pauline van Hirtum
investigator title: MD
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No