<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/NCT01713595</url>
  </required_header>
  <id_info>
    <org_study_id>12-001723</org_study_id>
    <nct_id>NCT01713595</nct_id>
  </id_info>
  <brief_title>Safety Study of Inhaled Saline in Acute Lung Injury</brief_title>
  <official_title>Inhaled Hypertonic Saline for the Treatment of Acute Lung Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine if an inhaled hypertonic saline solution has any effect on lung function in&#xD;
      patients with acute respiratory distress syndrome (ARDS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypertonic Saline (HS) aerosols have proven efficacious mucolytics in patient with cystic&#xD;
      fibrosis and are well tolerated in that population. Safety concerns in mechanically&#xD;
      ventilated patients with ARDS center primarily on HS's effects on lung water distribution&#xD;
      (intra vs. extra alveolar) and on airway reactivity. For that reason we plan a small&#xD;
      feasibility trial with narrowly focused physiologic endpoints, namely to measure the effects&#xD;
      of a single 5ml dose of 7% Saline aerosol on blood gas tensions, hemodynamics and the static&#xD;
      and dynamic properties of the relaxed respiratory system. This narrowly scoped study is to&#xD;
      lay the foundation for a larger multicenter intervention trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    difficult getting subjects&#xD;
  </why_stopped>
  <start_date>October 2013</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <phase>Phase 1</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>Dynamic Compliance of the Respiratory System</measure>
    <time_frame>Between 5 &amp; 10 minutes before aerosol delivery and 5 to 10 minutes after completion of the aerosol delivery</time_frame>
    <description>Changes in the static and dynamic properties of the respiratory system are surrogate markers of a change in airway tone and/or of the amount and distribution of alveolar edema</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient-Ventilator Interactions</measure>
    <time_frame>5 minutes before aersosol delivery, during the 15 minutes while aerosol is being delivered and 5 minutes after completion of the aerosol delivery</time_frame>
    <description>&quot;Fighting&quot; the ventilator may reflect irritant receptor feedback and related dyspnea and will speak to the feasibility/patient acceptance of the proposed therapy</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Arterial Blood Gas Tension</measure>
    <time_frame>Between 5 &amp; 10 minutes before aerosol delivery and 5 to 10 minutes after completion of the aerosol delivery</time_frame>
    <description>Changes in oxygenation and CO2 elimination reflect changes in ventilation-perfusion distribution secondary to changes in bronchomotor tone and/or lung water.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Pulmonary Edema</condition>
  <arm_group>
    <arm_group_label>Hypertonic Saline Aerosol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>a single 5ml dose of 7% Saline aerosol</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hypertonic Saline Aerosol</intervention_name>
    <description>A single 5ml dose of 7% Saline aerosol</description>
    <arm_group_label>Hypertonic Saline Aerosol</arm_group_label>
    <other_name>Nebulized hypertonic saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Study participants will include consenting adult patients (age &gt; 18), who had been&#xD;
             intubated and mechanically ventilated for &lt;72 hours and meet international consensus&#xD;
             criteria for ARDS.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard A Oeckler, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>October 4, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <last_update_submitted>August 14, 2015</last_update_submitted>
  <last_update_submitted_qc>August 14, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 17, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Richard A. Oeckler, M.D., Ph.D.</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine and Physiology</investigator_title>
  </responsible_party>
  <keyword>Acute Lung Injury</keyword>
  <keyword>Mechanical Ventilation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Injury</mesh_term>
    <mesh_term>Acute Lung Injury</mesh_term>
    <mesh_term>Pulmonary Edema</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/NCT01713595
org study id: 12-001723
nct id: NCT01713595
lead sponsor: 
has dmc: No
To determine if an inhaled hypertonic saline solution has any effect on lung function in
      patients with acute respiratory distress syndrome (ARDS).
Hypertonic Saline (HS) aerosols have proven efficacious mucolytics in patient with cystic
      fibrosis and are well tolerated in that population. Safety concerns in mechanically
      ventilated patients with ARDS center primarily on HS's effects on lung water distribution
      (intra vs. extra alveolar) and on airway reactivity. For that reason we plan a small
      feasibility trial with narrowly focused physiologic endpoints, namely to measure the effects
      of a single 5ml dose of 7% Saline aerosol on blood gas tensions, hemodynamics and the static
      and dynamic properties of the relaxed respiratory system. This narrowly scoped study is to
      lay the foundation for a larger multicenter intervention trial.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Dynamic Compliance of the Respiratory System
time frame: Between 5 & 10 minutes before aerosol delivery and 5 to 10 minutes after completion of the aerosol delivery
description: Changes in the static and dynamic properties of the respiratory system are surrogate markers of a change in airway tone and/or of the amount and distribution of alveolar edema
measure: Patient-Ventilator Interactions
time frame: 5 minutes before aersosol delivery, during the 15 minutes while aerosol is being delivered and 5 minutes after completion of the aerosol delivery
description: "Fighting" the ventilator may reflect irritant receptor feedback and related dyspnea and will speak to the feasibility/patient acceptance of the proposed therapy
measure: Arterial Blood Gas Tension
time frame: Between 5 & 10 minutes before aerosol delivery and 5 to 10 minutes after completion of the aerosol delivery
description: Changes in oxygenation and CO2 elimination reflect changes in ventilation-perfusion distribution secondary to changes in bronchomotor tone and/or lung water.
arm group label: Hypertonic Saline Aerosol
arm group type: Experimental
description: a single 5ml dose of 7% Saline aerosol
intervention type: Drug
intervention name: Hypertonic Saline Aerosol
description: A single 5ml dose of 7% Saline aerosol
arm group label: Hypertonic Saline Aerosol
other name: Nebulized hypertonic saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Richard A Oeckler, M.D., Ph.D.
role: Principal Investigator
affiliation: Mayo Clinic
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Richard A. Oeckler, M.D., Ph.D.
investigator title: Assistant Professor of Medicine and Physiology
mesh term: Lung Injury
mesh term: Acute Lung Injury
mesh term: Pulmonary Edema