<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/NCT01677117</url>
  </required_header>
  <id_info>
    <org_study_id>ECMO treatment</org_study_id>
    <nct_id>NCT01677117</nct_id>
  </id_info>
  <brief_title>Clinical Studies of the Effects of Extracorporeal Membrane Oxygenation for Severe ARDS Mortality</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Southeast University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Southeast University, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute respiratory distress syndrome (acute respiratory distress syndrome, ARDS) fatality rate&#xD;
      can be as high as 20% -41%, once progress is severe of ARDS, mortality rose to 90%, the main&#xD;
      cause of death was refractory hypoxemia. Mechanical ventilation as the main measure to&#xD;
      improve hypoxemia cannot correct all hypoxemia and relating complications of mechanical&#xD;
      ventilation, mechanical ventilation in the treatment of severe ARDS has gradually been&#xD;
      challenged. Extracorporeal membrane oxygenation（ECMO) technology matures, so that clinicians&#xD;
      have more choices in the face of hypoxemia, and with the deepening understanding of ECMO,&#xD;
      ECMO may become severe ARDS first-line treatment. Currently, ECMO therapy has been recognized&#xD;
      by the majority of medical workers. Therefore, we assume that accurately grasping the ECMO&#xD;
      indications and standardizing the implementation of treatment can significantly improve the&#xD;
      prognosis, shorter hospital stays, lower hospitalization costs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">December 2012</completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <enrollment type="Anticipated">25</enrollment>
  <condition>ECMO Treatment</condition>
  <eligibility>
    <study_pop>
      <textblock>
        severe ARDS patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        (1) age 18-70 years; (2) severe respiratory dysfunction (Murry score ≥ 3 points or clinical&#xD;
        optimized ventilation conditions pH remains &lt;7.2 patients); (3) PaCO2/FiO2 &lt;100mmHg; (4)&#xD;
        plateau pressure &gt;30cmH2O more than 6h，duration of no more than seven days; (5) with severe&#xD;
        respiratory dysfunction etiology reversible.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        (1) high levels pressure mechanical ventilation (PEEP&gt; 15-20cmH2O and / or Pplat&gt;&#xD;
        35-40cmH2O) over 7 days; (2) continued to receive high concentrations of oxygen (FiO2&gt; 80%)&#xD;
        is more than 7 days; (3) severe active bleeding; (4) within 24 hours of the surgery or head&#xD;
        injury with intracranial bleeding; (5) a variety of serious irreversible state; (6)&#xD;
        malignancy; (7) progressive pulmonary fibrosis; (8) can not surgical problems; (9) due to&#xD;
        cardiac dysfunction leading to ARDS.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>August 29, 2012</last_update_submitted>
  <last_update_submitted_qc>August 29, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 31, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Southeast University, China</investigator_affiliation>
    <investigator_full_name>Ling Liu</investigator_full_name>
    <investigator_title>Physician of Zhongda Hospital</investigator_title>
  </responsible_party>
  <!-- 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/NCT01677117
org study id: ECMO treatment
nct id: NCT01677117
lead sponsor: 
has dmc: Yes
Acute respiratory distress syndrome (acute respiratory distress syndrome, ARDS) fatality rate
      can be as high as 20% -41%, once progress is severe of ARDS, mortality rose to 90%, the main
      cause of death was refractory hypoxemia. Mechanical ventilation as the main measure to
      improve hypoxemia cannot correct all hypoxemia and relating complications of mechanical
      ventilation, mechanical ventilation in the treatment of severe ARDS has gradually been
      challenged. Extracorporeal membrane oxygenation（ECMO) technology matures, so that clinicians
      have more choices in the face of hypoxemia, and with the deepening understanding of ECMO,
      ECMO may become severe ARDS first-line treatment. Currently, ECMO therapy has been recognized
      by the majority of medical workers. Therefore, we assume that accurately grasping the ECMO
      indications and standardizing the implementation of treatment can significantly improve the
      prognosis, shorter hospital stays, lower hospitalization costs.
observational model: Case-Crossover
time perspective: Retrospective
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Southeast University, China
investigator full name: Ling Liu
investigator title: Physician of Zhongda Hospital