<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/NCT03262883</url>
  </required_header>
  <id_info>
    <org_study_id>Chronic critical illness</org_study_id>
    <nct_id>NCT03262883</nct_id>
  </id_info>
  <brief_title>The Prevalence of Chronic Critical Illness in Turkey</brief_title>
  <official_title>The Prevalence of Chronic Critical Illness Adult Intensive Care Units in Turkey</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yuzuncu Yıl University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kahramanmaras Sutcu Imam University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Izmir Ataturk Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Yuzuncu Yıl University</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>
      It is known that the number of Chronic Critical İllnes, an iatrogenic condition, increases&#xD;
      all over the world. The prevalence of Chronic Critical Illness in Turkey is unknown. The&#xD;
      investigators aimed to evaluate the etiology, comorbid conditions, demographic data,&#xD;
      prevalence, mortality and costs of these patient in intensive care units in Turkey. In this&#xD;
      multi-centered study, The investigators will retrospectively review the last 1 year of&#xD;
      patients receiving treatment at the Adult Intensive Care Unit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients who survive an acute critical illness in the Intensive Care Unit (ICU) may be&#xD;
      delayed in a situation where they are sometimes totally independent before hand due to&#xD;
      iatrogenic causes such as infections, dysfunctions, psychological disorders. This can take&#xD;
      weeks, sometimes months. This disease is called &quot;Chronic Critical Illness&quot; (CCI).&#xD;
&#xD;
      Most researchers associate CCI with the need for prolonged acute mechanical ventilation or&#xD;
      the opening of tracheostomy for prolonged acute mechanical ventilation. There is no single&#xD;
      condition that does not require an extended mechanical ventilation from CCI. In conclusion,&#xD;
      CCI is characterized by long-term care requiring survival and it is predicted that the cost&#xD;
      of these patients will increase with the new patients whose cost will be added in the coming&#xD;
      years. In the United States, the number of CCI is around 250,000, and this figure has&#xD;
      increased by 50-100% in the last 10 years. At least 50% of these patients die in one year and&#xD;
      less than 12% recover and become discharged. The annual cost of these patients' health care&#xD;
      system is over $ 20 billion. The prevalence of CCI in Turkey is still unknown. In this study,&#xD;
      it was aimed to investigate the prevalence of patients with Chronic Critical Syndrome in&#xD;
      intensive care units in Turkey.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">April 28, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 2018</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>Critical care unit mortality</measure>
    <time_frame>30 day and 90 day</time_frame>
    <description>The mortality change rates in the 30th days and 90th days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Critical care unit costs</measure>
    <time_frame>Duration of intensive care unit stay (8 day after the hospitalisation to sixth month)</time_frame>
    <description>Costs of patients staying in the intensive care unit</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2493</enrollment>
  <condition>Chronic Critical Illness</condition>
  <arm_group>
    <arm_group_label>Chronic Critical Illness</arm_group_label>
    <description>The patients who is over 18 years old and staying in the critical care unit at least 8 days. Additional criterias:&#xD;
Prolonged mechanical ventilation (longer than 96 hours)&#xD;
Tracheostomy&#xD;
Sepsis&#xD;
Serious injury (burn)&#xD;
Stroke (hemorhagic or ischemic)&#xD;
Traumatic brain injury</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The patient older than 18 years old staying in the intensive care unit longer than 8 days&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The patient who is over 18 years old, taking mechanical ventilation support and staying in&#xD;
        the critical care unit at least 8 days. Additional criterias; Clinical diagnosis of&#xD;
        following situations:&#xD;
&#xD;
          1. Prolonged mechanical ventilation&#xD;
&#xD;
          2. Tracheotomia&#xD;
&#xD;
          3. Sepsis&#xD;
&#xD;
          4. Serious injury (burn)&#xD;
&#xD;
          5. Stroke ( hemorhagic or ischemic)&#xD;
&#xD;
          6. Traumatic brain injury&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The patients who not having mechanical ventilation support&#xD;
&#xD;
          2. The patient staying less than 8 days in the intensive care unit&#xD;
&#xD;
          3. The patient younger than 18 years old&#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>Hilmi Demirkıran</last_name>
    <role>Principal Investigator</role>
    <affiliation>Official of the university</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yuzuncu Yıl University</name>
      <address>
        <city>Van</city>
        <zip>65080</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>October 8, 2019</last_update_submitted>
  <last_update_submitted_qc>October 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yuzuncu Yıl University</investigator_affiliation>
    <investigator_full_name>Hilmi Demirkiran, MD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Prolonged akut mechanical ventilation</keyword>
  <keyword>Tracheotomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03262883
org study id: Chronic critical illness
nct id: NCT03262883
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It is known that the number of Chronic Critical İllnes, an iatrogenic condition, increases
      all over the world. The prevalence of Chronic Critical Illness in Turkey is unknown. The
      investigators aimed to evaluate the etiology, comorbid conditions, demographic data,
      prevalence, mortality and costs of these patient in intensive care units in Turkey. In this
      multi-centered study, The investigators will retrospectively review the last 1 year of
      patients receiving treatment at the Adult Intensive Care Unit.
The patients who survive an acute critical illness in the Intensive Care Unit (ICU) may be
      delayed in a situation where they are sometimes totally independent before hand due to
      iatrogenic causes such as infections, dysfunctions, psychological disorders. This can take
      weeks, sometimes months. This disease is called "Chronic Critical Illness" (CCI).

      Most researchers associate CCI with the need for prolonged acute mechanical ventilation or
      the opening of tracheostomy for prolonged acute mechanical ventilation. There is no single
      condition that does not require an extended mechanical ventilation from CCI. In conclusion,
      CCI is characterized by long-term care requiring survival and it is predicted that the cost
      of these patients will increase with the new patients whose cost will be added in the coming
      years. In the United States, the number of CCI is around 250,000, and this figure has
      increased by 50-100% in the last 10 years. At least 50% of these patients die in one year and
      less than 12% recover and become discharged. The annual cost of these patients' health care
      system is over $ 20 billion. The prevalence of CCI in Turkey is still unknown. In this study,
      it was aimed to investigate the prevalence of patients with Chronic Critical Syndrome in
      intensive care units in Turkey.
observational model: Cohort
time perspective: Retrospective
measure: Critical care unit mortality
time frame: 30 day and 90 day
description: The mortality change rates in the 30th days and 90th days
measure: Critical care unit costs
time frame: Duration of intensive care unit stay (8 day after the hospitalisation to sixth month)
description: Costs of patients staying in the intensive care unit
arm group label: Chronic Critical Illness
description: The patients who is over 18 years old and staying in the critical care unit at least 8 days. Additional criterias:
Prolonged mechanical ventilation (longer than 96 hours)
Tracheostomy
Sepsis
Serious injury (burn)
Stroke (hemorhagic or ischemic)
Traumatic brain injury
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hilmi Demirkıran
role: Principal Investigator
affiliation: Official of the university
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Yuzuncu Yıl University
investigator full name: Hilmi Demirkiran, MD
investigator title: Assistant Professor
mesh term: Critical Illness
sharing ipd: Undecided