<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/NCT04405817</url>
  </required_header>
  <id_info>
    <org_study_id>ECLS-Jsph</org_study_id>
    <nct_id>NCT04405817</nct_id>
  </id_info>
  <brief_title>Outcome of Patients Treated With ECLS</brief_title>
  <official_title>Outcome of Patients Treated With Extracorporeal Life Support</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanjing Medical University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Extracorporeal life support (ECLS), also called extracorporeal membrane oxygenation (ECMO),&#xD;
      is an extracorporeal technique of providing effective circulatory and (or) respiratory&#xD;
      failure, with a growing number of critically ill patients benefit from it. The aim of this&#xD;
      study is to investigate the outcome of patients treated With ECMO, and to evaluate the&#xD;
      short-term and long-term outcomes of patients with ECLS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2012</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2025</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Composite of death from any cause, resuscitated circulatory arrest, and implantation of another mechanical circulatory support device</measure>
    <time_frame>30 days after ECMO implantation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>30 days after ECMO implantation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>12 months after ECMO implantation</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Cardiogenic Shock</condition>
  <condition>Cardiac Arrest</condition>
  <condition>Heart Failure</condition>
  <condition>Acute Respiratory Failure</condition>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ECMO</intervention_name>
    <description>ECMO for circulatory and/or respiratory support</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients receiving ECMO for circulatory and/or respiratory support&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients receiving ECMO for circulatory and/or respiratory support&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>100 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Yong-feng Shao</last_name>
    <role>Study Director</role>
    <affiliation>The First Affiliated Hospital with Nanjing Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hong Liu, MD</last_name>
    <phone>18801281613</phone>
    <email>DR.HONGLIU@FOXMAIL.COM</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yong-feng Shao, MD</last_name>
    <phone>02568303100</phone>
    <email>yfshaojph@sina.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The first affiliated hospital of nanjing medical university</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hong Liu, MD</last_name>
      <phone>188012181613</phone>
      <email>dr.hongliu@foxmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 26, 2020</last_update_submitted>
  <last_update_submitted_qc>May 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nanjing Medical University</investigator_affiliation>
    <investigator_full_name>Hong Liu</investigator_full_name>
    <investigator_title>Investigator of Department of Cardiac Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Acute Lung Injury</mesh_term>
    <mesh_term>Shock, Cardiogenic</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/NCT04405817
org study id: ECLS-Jsph
nct id: NCT04405817
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Extracorporeal life support (ECLS), also called extracorporeal membrane oxygenation (ECMO),
      is an extracorporeal technique of providing effective circulatory and (or) respiratory
      failure, with a growing number of critically ill patients benefit from it. The aim of this
      study is to investigate the outcome of patients treated With ECMO, and to evaluate the
      short-term and long-term outcomes of patients with ECLS.
observational model: Cohort
time perspective: Prospective
measure: Composite of death from any cause, resuscitated circulatory arrest, and implantation of another mechanical circulatory support device
time frame: 30 days after ECMO implantation
measure: All-cause mortality
time frame: 30 days after ECMO implantation
measure: All-cause mortality
time frame: 12 months after ECMO implantation
intervention type: Device
intervention name: ECMO
description: ECMO for circulatory and/or respiratory support
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 100 Years
last name: Yong-feng Shao
role: Study Director
affiliation: The First Affiliated Hospital with Nanjing Medical University
last name: Hong Liu, MD
phone: 18801281613
email: DR.HONGLIU@FOXMAIL.COM
last name: Yong-feng Shao, MD
phone: 02568303100
email: yfshaojph@sina.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Nanjing Medical University
investigator full name: Hong Liu
investigator title: Investigator of Department of Cardiac Surgery
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Respiratory Insufficiency
mesh term: Acute Lung Injury
mesh term: Shock, Cardiogenic
sharing ipd: Undecided