<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/NCT01685112</url>
  </required_header>
  <id_info>
    <org_study_id>201207079RIC</org_study_id>
    <nct_id>NCT01685112</nct_id>
  </id_info>
  <brief_title>Comparison of ECMO Use and Conventional Treatment in Adults With Septic Shock</brief_title>
  <official_title>Comparison of ECMO Use and Conventional Treatment in Adults With Septic Shock</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Although few cases reported successful treatment of septic shock using extracorporeal&#xD;
      membrane oxygenation (ECMO) in adults, no studies compared ECMO to conventional treatment&#xD;
      (without ECMO) as treatment for adults with septic shock. Since it is difficult to conduct a&#xD;
      randomized study to allocate patients in such critical condition, we aimed to conduct a&#xD;
      retrospective observational study using propensity score matched analysis to compare the&#xD;
      survival of adults with septic shock treated by ECMO or conventional treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">August 2013</completion_date>
  <primary_completion_date type="Anticipated">August 2013</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>In hospital mortality</measure>
    <time_frame>30 days</time_frame>
    <description>inhospital mortality as primary outcome, mean length of hospital stay around 30 days</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Septic Shock</condition>
  <arm_group>
    <arm_group_label>Conventional Group</arm_group_label>
    <description>Patients who developed refractory shock, but didn't received ECMO as salvage treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ECMO group</arm_group_label>
    <description>Patient who have septic shock, and progreseed to have ECMO as salvage therapy</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adults patient who admitted to ICU and had severe sepsis and progressed to septic shock&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt;20&#xD;
&#xD;
          -  admitted at ICU&#xD;
&#xD;
          -  septic shock&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  nil&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>YuChung Chuang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>YuChung Chuang, MD</last_name>
    <phone>886-972652532</phone>
    <email>weischuang@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>YuChung Chuang, MD</last_name>
      <phone>886-972652532</phone>
      <email>weischuang@gmail.com</email>
    </contact>
    <investigator>
      <last_name>YuChung Chuang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <last_update_submitted>October 10, 2012</last_update_submitted>
  <last_update_submitted_qc>October 10, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 12, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>adults</keyword>
  <keyword>ECMO</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shock, Septic</mesh_term>
    <mesh_term>Shock</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/NCT01685112
org study id: 201207079RIC
nct id: NCT01685112
lead sponsor: 
has dmc: No
Although few cases reported successful treatment of septic shock using extracorporeal
      membrane oxygenation (ECMO) in adults, no studies compared ECMO to conventional treatment
      (without ECMO) as treatment for adults with septic shock. Since it is difficult to conduct a
      randomized study to allocate patients in such critical condition, we aimed to conduct a
      retrospective observational study using propensity score matched analysis to compare the
      survival of adults with septic shock treated by ECMO or conventional treatment.
observational model: Cohort
time perspective: Retrospective
measure: In hospital mortality
time frame: 30 days
description: inhospital mortality as primary outcome, mean length of hospital stay around 30 days
arm group label: Conventional Group
description: Patients who developed refractory shock, but didn't received ECMO as salvage treatment
arm group label: ECMO group
description: Patient who have septic shock, and progreseed to have ECMO as salvage therapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: YuChung Chuang, MD
role: Principal Investigator
affiliation: National Taiwan University Hospital
last name: YuChung Chuang, MD
phone: 886-972652532
email: weischuang@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Taiwan
responsible party type: Sponsor
mesh term: Shock, Septic
mesh term: Shock