<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/NCT02260583</url>
  </required_header>
  <id_info>
    <org_study_id>176/2013</org_study_id>
    <nct_id>NCT02260583</nct_id>
  </id_info>
  <brief_title>Effect of Extracorporeal CO2 Removal in Stable Hypercapnic COPD Patients</brief_title>
  <official_title>EFFECT OF EXTRACORPOREAL CO2 REMOVAL IN STABLE COPD PATIENTS WITH CHRONIC HYPERCAPNIC RESPIRATORY FAILURE:A PILOT STUDY</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Azienda Ospedaliero-Universitaria di Bologna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS Azienda Ospedaliero-Universitaria di Bologna</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic hypercapnic respiratory failure is common in stable COPD patients in a terminal phase&#xD;
      of their disease In an attempt to correct or slow down the rate of rise of PaCO2, long-term&#xD;
      noninvasive mechanical ventilation (NIV) has been proposed.&#xD;
&#xD;
      Only very few studies demonstrated the clinical efficacy of NIV. Indeed this technique is not&#xD;
      always well tolerated and therefore it may be effective only in a subset of patients The aim&#xD;
      of this study is to assess the feasibility and safety of &quot;one shot&quot; extrcorporeal CO2 removal&#xD;
      device, in reducing the PaCO2 level&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic hypercapnic respiratory failure is common in stable COPD patients in a terminal phase&#xD;
      of their disease In an attempt to correct or slow down the rate of rise of PaCO2, long-term&#xD;
      noninvasive mechanical ventilation (NIV) has been proposed.&#xD;
&#xD;
      Only very few studies demonstrated the clinical efficacy of NIV. Indeed this technique is not&#xD;
      always well tolerated and therefore it may be effective only in a subset of patients Recently&#xD;
      extracorporeal CO2 removal have been shown to avoid the need of endotracheal intubation in&#xD;
      COPD patients with an episode of Acute Hypercapnic Respiratory Failure In this pilot&#xD;
      physiological study we want to assess the safety and efficacy of this technique in reducing&#xD;
      the PaCO2 level in those COPD patients with chronic hypercapnic respiratory failure non&#xD;
      responding to chronic NIV.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>arterial blood gases</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>respiratory rate, dyspnea</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease Patients</condition>
  <condition>Chronic Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>extracorporeal CO2 removal device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the patients will be enroll to start a &quot;one shot&quot; session of extracorporeal CO2 removal. The patient will be connected to the device via a double lumen catheter inserted in the femoral vein An ECCO2R device based on a modified continuous venovenous hemofiltration system will be used. Blood flow is driven by a roller nonocclusive pump (0-450 mL/min) through a polypropylene oxygenator ; priming volume, 100 mL; contact surface area, 1.35 m2; maximum blood flow rate, 7 L/min) that is connected to a fresh gas flow source delivering 100% oxygen at a constant rate of 8 L/min. Exiting the oxygenator, blood is driven to a hemofilter.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>extracorporeal CO2 device</intervention_name>
    <description>An ECCO2R device based on a modified continuous venovenous hemofiltration system will be used</description>
    <arm_group_label>extracorporeal CO2 removal device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COPD ( FEV1/CVF &lt;0.70 post bronchodilation)&#xD;
&#xD;
          -  stable PaCO2 &gt;55 mmHg non respondent to long-term NIV (at least one week). This means&#xD;
             a decrease in PaCO2 during spontaneous breathing, at least 4 hrs after the termination&#xD;
             of NIV, of&lt; 6%&#xD;
&#xD;
          -  pH &gt; 7.35&#xD;
&#xD;
          -  clinical stability&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mean Arterial Pressure &lt; 60 mmHg&#xD;
&#xD;
          -  contra-indication to heparin&#xD;
&#xD;
          -  Body Mass Index (BMI) &gt; 30 kg/m2;&#xD;
&#xD;
          -  presence of sleep apnea or overall syndrome&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>stefano nava</last_name>
    <role>Principal Investigator</role>
    <affiliation>sant'orsola malpighi hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>stefano nava</last_name>
    <phone>051 6364017</phone>
    <email>stefano.nava@aosp.bo.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>san'Orsola Malpighi Hospital, Bologna ITALY</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>stefano nava, md</last_name>
      <phone>051 6364017</phone>
      <email>stefano.nava@aosp.bo.it</email>
    </contact>
    <contact_backup>
      <last_name>lara pisani, md</last_name>
      <phone>0516363253</phone>
      <email>lara.pisani@unibo.it</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>December 27, 2017</last_update_submitted>
  <last_update_submitted_qc>December 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Azienda Ospedaliero-Universitaria di Bologna</investigator_affiliation>
    <investigator_full_name>dr. Stefano Nava</investigator_full_name>
    <investigator_title>PRofessor of Respiratory Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Respiratory Insufficiency</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/NCT02260583
org study id: 176/2013
nct id: NCT02260583
lead sponsor: 
has dmc: No
Chronic hypercapnic respiratory failure is common in stable COPD patients in a terminal phase
      of their disease In an attempt to correct or slow down the rate of rise of PaCO2, long-term
      noninvasive mechanical ventilation (NIV) has been proposed.

      Only very few studies demonstrated the clinical efficacy of NIV. Indeed this technique is not
      always well tolerated and therefore it may be effective only in a subset of patients The aim
      of this study is to assess the feasibility and safety of "one shot" extrcorporeal CO2 removal
      device, in reducing the PaCO2 level
Chronic hypercapnic respiratory failure is common in stable COPD patients in a terminal phase
      of their disease In an attempt to correct or slow down the rate of rise of PaCO2, long-term
      noninvasive mechanical ventilation (NIV) has been proposed.

      Only very few studies demonstrated the clinical efficacy of NIV. Indeed this technique is not
      always well tolerated and therefore it may be effective only in a subset of patients Recently
      extracorporeal CO2 removal have been shown to avoid the need of endotracheal intubation in
      COPD patients with an episode of Acute Hypercapnic Respiratory Failure In this pilot
      physiological study we want to assess the safety and efficacy of this technique in reducing
      the PaCO2 level in those COPD patients with chronic hypercapnic respiratory failure non
      responding to chronic NIV.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: arterial blood gases
time frame: 30 days
measure: respiratory rate, dyspnea
time frame: 30 days
arm group label: extracorporeal CO2 removal device
arm group type: Experimental
description: the patients will be enroll to start a "one shot" session of extracorporeal CO2 removal. The patient will be connected to the device via a double lumen catheter inserted in the femoral vein An ECCO2R device based on a modified continuous venovenous hemofiltration system will be used. Blood flow is driven by a roller nonocclusive pump (0-450 mL/min) through a polypropylene oxygenator ; priming volume, 100 mL; contact surface area, 1.35 m2; maximum blood flow rate, 7 L/min) that is connected to a fresh gas flow source delivering 100% oxygen at a constant rate of 8 L/min. Exiting the oxygenator, blood is driven to a hemofilter.
intervention type: Device
intervention name: extracorporeal CO2 device
description: An ECCO2R device based on a modified continuous venovenous hemofiltration system will be used
arm group label: extracorporeal CO2 removal device
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: stefano nava
role: Principal Investigator
affiliation: sant'orsola malpighi hospital
last name: stefano nava
phone: 051 6364017
email: stefano.nava@aosp.bo.it
facility: 
status: Recruiting
contact: 
contact backup: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
investigator full name: dr. Stefano Nava
investigator title: PRofessor of Respiratory Medicine
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Respiratory Insufficiency