<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/NCT03827863</url>
  </required_header>
  <id_info>
    <org_study_id>HS-1615</org_study_id>
    <nct_id>NCT03827863</nct_id>
  </id_info>
  <brief_title>Acute CorPulmonale and ARDS Circulation Protection China Study China (ACPC)</brief_title>
  <official_title>The Prospective Observational Study of ARDS Related Acute CorPulmonale and the Randomized Controlled Study of ARDS Aimed Circulation Protection China (ACPC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</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>
      The investigators established a national cohort of Chinese ARDS with Acute CorPulmonale to&#xD;
      enable prospective observational studies. The goals are the following.&#xD;
&#xD;
      First, morbidity and mortality rate of ARDS with ACP in the ICU across Chinese mainland.&#xD;
&#xD;
      Second, forming the diagnostic ultrasound strategy of ARDS-ACP, namely TRIP procedures. And&#xD;
      predictive value of diagnostic strategy for ACP or prognosis of ACP were calculated.&#xD;
&#xD;
      Third, comparison of ventilator parameters for ACP and non-ACP or survivor and non-survisors,&#xD;
      which reaveald that of inappropriate mechanical ventilation on circulation and prognosis.&#xD;
      Screening for risk factors of ARDS with ACP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acute respiratory distress syndrome (ARDS) is an acute and critical illness characterized by&#xD;
      progressive dyspnea and refractory hypoxemia caused by intrapulmonary or extrapulmonary&#xD;
      factors. The mortality rate of ARDS is extremely high. ACP caused by pulmonary circulatory&#xD;
      disorder is its main clinical feature, which is related to the severity of lung injury in&#xD;
      ARDS patients. It has been recognized that the ACP is an independent risk factor for the&#xD;
      prognosis of patients with ARDS. Positive pressure mechanical ventilation is an important&#xD;
      ARDS treatment strategy for ARDS. Especially the lung protective ventilation strategy with&#xD;
      &quot;small tidal volume and increased PEEP&quot; as the core content, which achieved a milestone of&#xD;
      lower the mortality of ARDS. However, improper use of positive pressure mechanical&#xD;
      ventilation can increase right ventricular load and increase mortality in ARDS patients.&#xD;
      Therefore, understanding the effect of positive pressure mechanical ventilation on right&#xD;
      heart function in patients with ARDS is important for prevention and treatment for the ACP of&#xD;
      ARDS and reduction of ARDS mortality.&#xD;
&#xD;
      The alveolar edema, alveolar collapse, and hypoxic pulmonary vasoconstriction loss caused by&#xD;
      increased pulmonary vascular permeability and release of inflammatory mediators resulted in&#xD;
      loss of ventilation/blood flow, severe hypoxemia, pulmonary vasospasm, pulmonary&#xD;
      microthrombus formation, which increased pulmonary arterial pressure and even APC. Positive&#xD;
      pressure mechanical ventilation maintains alveolar ventilation through positive airway&#xD;
      pressure, prevents premature alveolar collapse by positive end expiratory pressure (PEEP),&#xD;
      changes intrathoracic pressure and lung volume, and affects the right ventricle load.&#xD;
      Different studies have found that the incidence of ACP in patients with ARDS is from 22% to&#xD;
      60%. Jardin, et al found that patients with ARDS had a significant increase in ACP and&#xD;
      mortality when the airway pressure was greater than 26 cmH2O, which revealed that the&#xD;
      difference in positive pressure mechanical ventilation settings has a significant difference&#xD;
      in the right heart function of ARDS patients. Mekontso, et al propose a simple clinical risk&#xD;
      score for early identification of ACP included pneumonia as cause of ARDS, driving pressure&#xD;
      ≥18cmH2O, PaO2/FiO2 ratio&lt;150 mmHg, and PaCO2≥48mmHg. However, for the morbidity and&#xD;
      mortality of ACP in ARDS, the related risk factors and criteria are different due to the&#xD;
      influence of the different etiology of ARDS and the different study time. For these reasons,&#xD;
      the investigators established a national cohort of Chinese ARDS with Acute CorPulmonale to&#xD;
      enable prospective observational studies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">April 1, 2019</start_date>
  <completion_date type="Anticipated">March 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2020</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>28 days SURVIVAL</measure>
    <time_frame>28 days after ICU admission</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>length of stay of ICU</measure>
    <time_frame>1 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>mechanical ventilation time</measure>
    <time_frame>1 years</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>ARDS (Acute Respiratory Distress Syndrome)</condition>
  <condition>Acute Cor Pulmonale</condition>
  <arm_group>
    <arm_group_label>ARDS WITH ACP</arm_group_label>
    <description>Diagnostic criteria for ARDS ARDS defined as within 1 week of a known clinical insult or new or worsening respiratory symptoms. ARDS was classified as mild (200 mmHg &lt; PaO2/FIO2≤300 mmHg), moderate (100 mmHg &lt; PaO2/FIO2≤200 mmHg) and severe (PaO2/FIO2≤100 mmHg) according to the value of PaO2/FiO2 ratio. Importantly, the PaO2/FiO2 ratio value is considered only with a CPAP or PEEP value of at least 5 cmH2O.&#xD;
Ultrasound diagnostic criteria for ACP The specific diagnostic parameters are as follows: TR&gt;2.8m/s; RVEDA/LVEDA&gt;0.6 or Right ventricle/left ventricle basal diameter ratio&gt;1.0 or systolic D sign; IVC &gt;2cm with decreased inspiratory collapse; Pulmonary Regurgitation Velocity &gt;2.2m/s.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ARDS WITHOUT ACP</arm_group_label>
    <description>Diagnosis as ARDS but no ultrasound evidence of ACP.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TTE</intervention_name>
    <description>TTE to detect the heart function</description>
    <arm_group_label>ARDS WITH ACP</arm_group_label>
    <arm_group_label>ARDS WITHOUT ACP</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood specimen, morning blood samples were collected at the baseline assessment and will be&#xD;
      collected at the follow-ups. After simple processing, the supernatant was separated after&#xD;
      centrifugation and frozen at -80°C at each participating centre, and then transported to the&#xD;
      central laboratory by cold chain every 3 months for future use.&#xD;
&#xD;
      With these specimens, we intend to explore for novel biomarkers that reflect ARDS progression&#xD;
      and develop predictive models to identify a subgroup population among ARDS with ACP who are&#xD;
      at high risk. Examples of biomarkers to explore include glycocalyx shedding, vascular&#xD;
      endothelium, and inflammatory factors.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        the critically patients admitted to ICU&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18≤ aged ≤85 years old&#xD;
&#xD;
          -  received a diagnosis of ARDS with Acute CorPulmonal&#xD;
&#xD;
          -  provided signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  are diagnosed as cardiogenic pulmonary edema&#xD;
&#xD;
          -  are diagnosed as Idiopathic pulmonary fibrosis acute exacerbation&#xD;
&#xD;
          -  are participating in other interventional clinical trials&#xD;
&#xD;
          -  refused to continue to participate in the study or refused further treatment&#xD;
&#xD;
          -  unable to complete the study procedure even if assisted and otherwise unable to comply&#xD;
             with the study protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Hui Xu</last_name>
      <phone>+86 10 69155817</phone>
      <email>pumchkyc@126.com</email>
    </contact>
    <investigator>
      <last_name>Longxiang Su, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>February 1, 2019</last_update_submitted>
  <last_update_submitted_qc>February 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>Acute Lung Injury</mesh_term>
    <mesh_term>Pulmonary Heart Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>When the study begin.</ipd_description>
  </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/NCT03827863
org study id: HS-1615
nct id: NCT03827863
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators established a national cohort of Chinese ARDS with Acute CorPulmonale to
      enable prospective observational studies. The goals are the following.

      First, morbidity and mortality rate of ARDS with ACP in the ICU across Chinese mainland.

      Second, forming the diagnostic ultrasound strategy of ARDS-ACP, namely TRIP procedures. And
      predictive value of diagnostic strategy for ACP or prognosis of ACP were calculated.

      Third, comparison of ventilator parameters for ACP and non-ACP or survivor and non-survisors,
      which reaveald that of inappropriate mechanical ventilation on circulation and prognosis.
      Screening for risk factors of ARDS with ACP.
Acute respiratory distress syndrome (ARDS) is an acute and critical illness characterized by
      progressive dyspnea and refractory hypoxemia caused by intrapulmonary or extrapulmonary
      factors. The mortality rate of ARDS is extremely high. ACP caused by pulmonary circulatory
      disorder is its main clinical feature, which is related to the severity of lung injury in
      ARDS patients. It has been recognized that the ACP is an independent risk factor for the
      prognosis of patients with ARDS. Positive pressure mechanical ventilation is an important
      ARDS treatment strategy for ARDS. Especially the lung protective ventilation strategy with
      "small tidal volume and increased PEEP" as the core content, which achieved a milestone of
      lower the mortality of ARDS. However, improper use of positive pressure mechanical
      ventilation can increase right ventricular load and increase mortality in ARDS patients.
      Therefore, understanding the effect of positive pressure mechanical ventilation on right
      heart function in patients with ARDS is important for prevention and treatment for the ACP of
      ARDS and reduction of ARDS mortality.

      The alveolar edema, alveolar collapse, and hypoxic pulmonary vasoconstriction loss caused by
      increased pulmonary vascular permeability and release of inflammatory mediators resulted in
      loss of ventilation/blood flow, severe hypoxemia, pulmonary vasospasm, pulmonary
      microthrombus formation, which increased pulmonary arterial pressure and even APC. Positive
      pressure mechanical ventilation maintains alveolar ventilation through positive airway
      pressure, prevents premature alveolar collapse by positive end expiratory pressure (PEEP),
      changes intrathoracic pressure and lung volume, and affects the right ventricle load.
      Different studies have found that the incidence of ACP in patients with ARDS is from 22% to
      60%. Jardin, et al found that patients with ARDS had a significant increase in ACP and
      mortality when the airway pressure was greater than 26 cmH2O, which revealed that the
      difference in positive pressure mechanical ventilation settings has a significant difference
      in the right heart function of ARDS patients. Mekontso, et al propose a simple clinical risk
      score for early identification of ACP included pneumonia as cause of ARDS, driving pressure
      ≥18cmH2O, PaO2/FiO2 ratio<150 mmHg, and PaCO2≥48mmHg. However, for the morbidity and
      mortality of ACP in ARDS, the related risk factors and criteria are different due to the
      influence of the different etiology of ARDS and the different study time. For these reasons,
      the investigators established a national cohort of Chinese ARDS with Acute CorPulmonale to
      enable prospective observational studies.
observational model: Cohort
time perspective: Prospective
measure: 28 days SURVIVAL
time frame: 28 days after ICU admission
measure: length of stay of ICU
time frame: 1 years
measure: mechanical ventilation time
time frame: 1 years
arm group label: ARDS WITH ACP
description: Diagnostic criteria for ARDS ARDS defined as within 1 week of a known clinical insult or new or worsening respiratory symptoms. ARDS was classified as mild (200 mmHg < PaO2/FIO2≤300 mmHg), moderate (100 mmHg < PaO2/FIO2≤200 mmHg) and severe (PaO2/FIO2≤100 mmHg) according to the value of PaO2/FiO2 ratio. Importantly, the PaO2/FiO2 ratio value is considered only with a CPAP or PEEP value of at least 5 cmH2O.
Ultrasound diagnostic criteria for ACP The specific diagnostic parameters are as follows: TR>2.8m/s; RVEDA/LVEDA>0.6 or Right ventricle/left ventricle basal diameter ratio>1.0 or systolic D sign; IVC >2cm with decreased inspiratory collapse; Pulmonary Regurgitation Velocity >2.2m/s.
arm group label: ARDS WITHOUT ACP
description: Diagnosis as ARDS but no ultrasound evidence of ACP.
intervention type: Device
intervention name: TTE
description: TTE to detect the heart function
arm group label: ARDS WITH ACP
arm group label: ARDS WITHOUT ACP
Blood specimen, morning blood samples were collected at the baseline assessment and will be
      collected at the follow-ups. After simple processing, the supernatant was separated after
      centrifugation and frozen at -80°C at each participating centre, and then transported to the
      central laboratory by cold chain every 3 months for future use.

      With these specimens, we intend to explore for novel biomarkers that reflect ARDS progression
      and develop predictive models to identify a subgroup population among ARDS with ACP who are
      at high risk. Examples of biomarkers to explore include glycocalyx shedding, vascular
      endothelium, and inflammatory factors.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury
mesh term: Pulmonary Heart Disease
sharing ipd: Undecided
ipd description: When the study begin.