<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/NCT01694147</url>
  </required_header>
  <id_info>
    <org_study_id>99-3957B</org_study_id>
    <nct_id>NCT01694147</nct_id>
  </id_info>
  <brief_title>EVLWI Exhibits Pulmonary and Systemic Permeability in Sepsis Related ALI/ARDS</brief_title>
  <official_title>Extravascular Lung Water Index Exhibits Pulmonary and Systemic Permeability in Patients With Sepsis Related Acute Lung Injury/Acute Respiratory Distress Syndrome.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the possible mechanisms of pulmonary and systemic permeability change&#xD;
      including cytokine, extravascular lung water index (EVLWI), and oxygenation parameters in&#xD;
      patients with sepsis related acute lung injury (ALI)/acute respiratory distress syndrome&#xD;
      (ARDS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This investigation is a prospective control study. Informed consents will be obtained from&#xD;
      all patients or their surrogates prior to the procedure of EVLWI measurement and blood&#xD;
      sampling for molecular measurement including cytokines.&#xD;
&#xD;
      From July 2011 to June 2014, consecutive septic patients with ARDS in intensive care units&#xD;
      (ICUs) will be enrolled at Chang Gung Memorial Hospital, a university-affiliated hospital in&#xD;
      Taiwan. EVLWI will be measured by PiCCO monitoring system. Serum cytokine such as&#xD;
      endothelin-1, TNF-alfa, IL-6, Tie-1, Tie-2, angiopoietin-1, angiopoietin-2,VEGF and&#xD;
      thrombomodulin will be measured.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2011</start_date>
  <completion_date type="Anticipated">January 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>vascular permeability of sepsis related ALI/ARDS</measure>
    <time_frame>3 days</time_frame>
    <description>vascular permeability (day 1 and 3 EVLWI, lung permeability, 24hr fluid balance, microalbuminuria, DAMPs/RAGE, Ang-1, 2 and TIE-2 level, will be detected in the blood sampling) and sepsis-induced ALI/ARDS.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>relationship between endothelial injury and vascular permeability.</measure>
    <time_frame>3 days</time_frame>
    <description>relationship between endothelial injury (serum TM, vWF, VEGF, TIE-2 increase and imbalance of ANG-1/ANG-2) and vascular permeability in patients with sepsis related ALI/ARDS.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Sepsis Related Acute Lung Injury/Acute Respiratory Distress Syndrome</condition>
  <arm_group>
    <arm_group_label>patients with sepsis related ALI/ARDS.</arm_group_label>
    <description>Consecutive septic patients with ALI/ARDS in medical intensive care units (ICUs) will be enrolled. EVLWI will be measured by PiCCO monitoring system.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PiCCO monitoring system</intervention_name>
    <description>The EVLW measurement will be based on transpulmonary thermodilution method. This method was recently introduced as part of the PiCCO plus system (Pulsion Medical System, Munich, Germany), for monitoring severe sepsis patients being treated in medical ICUs. This method only used a single indicator (cold saline solution), and demonstrated a satisfactory correlation with the gravimetric method. A 4-F arterial catheter (PulsiocathPV2014L16; Pulsion Medical Systems, Munich, Germany) was positioned in the descending aorta via the femoral artery using the Seldinger technique. The femoral arterial catheter and a standard central venous catheter were connected to pressure transducers, and also to an integrated bedside monitor (PiCCO; Pulsion Medical Systems).</description>
    <arm_group_label>patients with sepsis related ALI/ARDS.</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      To measure the relationship between endothelial injury (serum TM, vWF, VEGF, TIE-2 increase&#xD;
      and imbalance of ANG-1/ANG-2) and vascular permeability and EVLWI in patients, 20ml&#xD;
      peripheral blood will be sampling retented on day 1 and day 3 after including.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Septic patients receiving endotracheal mechanical ventilation for hypoxemic acute&#xD;
        respiratory failure were eligible if the following criteria were met for no more than 48&#xD;
        hours before enrollment: ratio of partial pressure of arterial oxygen over fraction of&#xD;
        inspired oxygen (PaO2:FIO2) no greater than 300 mm Hg at time of enrollment, recent&#xD;
        appearance of bilateral pulmonary infiltrates consistent with edema, and no clinical&#xD;
        evidence of left atrial hypertension (pulmonary-capillary wedge pressure _18 mm Hg, when&#xD;
        available).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  sepsis in ICU within 48 hours,&#xD;
&#xD;
          -  mechanical ventilator use,&#xD;
&#xD;
          -  PaO2/FiO2 &lt; 300,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age younger than 20 years,&#xD;
&#xD;
          -  known pregnancy,&#xD;
&#xD;
          -  participation in another trial within 30 days before meeting the eligibility criteria,&#xD;
             and&#xD;
&#xD;
          -  terminal malignancy.&#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_contact>
    <last_name>Fu-Tsai Chung, MD</last_name>
    <phone>+886-3-3281200</phone>
    <phone_ext>8468</phone_ext>
    <email>vikingchung@yahoo.com.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chung Gung Memorial Hospital</name>
      <address>
        <city>Linkou</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fu-Tsai Chung, MD</last_name>
      <phone>+886-3-3281200</phone>
      <phone_ext>8468</phone_ext>
      <email>vikingchung@yahoo.com.tw</email>
    </contact>
    <investigator>
      <last_name>Fu-Tsai Chung, 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 23, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>July 27, 2015</last_update_submitted>
  <last_update_submitted_qc>July 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Gung Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Chung Fu-Tsai</investigator_full_name>
    <investigator_title>Attending physician</investigator_title>
  </responsible_party>
  <keyword>relationship</keyword>
  <keyword>endothelial injury</keyword>
  <keyword>vascular permeability</keyword>
  <keyword>severe sepsis related ALI/ARDS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sepsis</mesh_term>
    <mesh_term>Toxemia</mesh_term>
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Acute Lung Injury</mesh_term>
    <mesh_term>Lung Injury</mesh_term>
    <mesh_term>Syndrome</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/NCT01694147
org study id: 99-3957B
nct id: NCT01694147
lead sponsor: 
has dmc: Yes
To investigate the possible mechanisms of pulmonary and systemic permeability change
      including cytokine, extravascular lung water index (EVLWI), and oxygenation parameters in
      patients with sepsis related acute lung injury (ALI)/acute respiratory distress syndrome
      (ARDS).
This investigation is a prospective control study. Informed consents will be obtained from
      all patients or their surrogates prior to the procedure of EVLWI measurement and blood
      sampling for molecular measurement including cytokines.

      From July 2011 to June 2014, consecutive septic patients with ARDS in intensive care units
      (ICUs) will be enrolled at Chang Gung Memorial Hospital, a university-affiliated hospital in
      Taiwan. EVLWI will be measured by PiCCO monitoring system. Serum cytokine such as
      endothelin-1, TNF-alfa, IL-6, Tie-1, Tie-2, angiopoietin-1, angiopoietin-2,VEGF and
      thrombomodulin will be measured.
observational model: Case-Only
time perspective: Prospective
measure: vascular permeability of sepsis related ALI/ARDS
time frame: 3 days
description: vascular permeability (day 1 and 3 EVLWI, lung permeability, 24hr fluid balance, microalbuminuria, DAMPs/RAGE, Ang-1, 2 and TIE-2 level, will be detected in the blood sampling) and sepsis-induced ALI/ARDS.
measure: relationship between endothelial injury and vascular permeability.
time frame: 3 days
description: relationship between endothelial injury (serum TM, vWF, VEGF, TIE-2 increase and imbalance of ANG-1/ANG-2) and vascular permeability in patients with sepsis related ALI/ARDS.
arm group label: patients with sepsis related ALI/ARDS.
description: Consecutive septic patients with ALI/ARDS in medical intensive care units (ICUs) will be enrolled. EVLWI will be measured by PiCCO monitoring system.
intervention type: Device
intervention name: PiCCO monitoring system
description: The EVLW measurement will be based on transpulmonary thermodilution method. This method was recently introduced as part of the PiCCO plus system (Pulsion Medical System, Munich, Germany), for monitoring severe sepsis patients being treated in medical ICUs. This method only used a single indicator (cold saline solution), and demonstrated a satisfactory correlation with the gravimetric method. A 4-F arterial catheter (PulsiocathPV2014L16; Pulsion Medical Systems, Munich, Germany) was positioned in the descending aorta via the femoral artery using the Seldinger technique. The femoral arterial catheter and a standard central venous catheter were connected to pressure transducers, and also to an integrated bedside monitor (PiCCO; Pulsion Medical Systems).
arm group label: patients with sepsis related ALI/ARDS.
To measure the relationship between endothelial injury (serum TM, vWF, VEGF, TIE-2 increase
      and imbalance of ANG-1/ANG-2) and vascular permeability and EVLWI in patients, 20ml
      peripheral blood will be sampling retented on day 1 and day 3 after including.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Fu-Tsai Chung, MD
phone: +886-3-3281200
phone ext: 8468
email: vikingchung@yahoo.com.tw
facility: 
status: Recruiting
contact: 
investigator: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Chang Gung Memorial Hospital
investigator full name: Chung Fu-Tsai
investigator title: Attending physician
mesh term: Sepsis
mesh term: Toxemia
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury
mesh term: Lung Injury
mesh term: Syndrome