<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/NCT01714583</url>
  </required_header>
  <id_info>
    <org_study_id>NHLBI T32 HL007106-34</org_study_id>
    <nct_id>NCT01714583</nct_id>
  </id_info>
  <brief_title>The Relationship Between Positive End Expiratory Pressure and Cardiac Index in Patients With Acute Respiratory Distress Syndrome (ARDS) Managed on a Fluid Protocol</brief_title>
  <official_title>The Relationship Between Positive End Expiratory Pressure and Cardiac Index in Patients With ARDS Managed on a Fluid Protocol: A Secondary Analysis of a Prospective Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the association between positive end-expiratory&#xD;
      pressure (PEEP) setting and cardiac function, as measured by cardiac index, in patients with&#xD;
      acute respiratory distress syndrome (ARDS) who were managed on the NHLBI ARDS Network Fluid&#xD;
      and Catheter Treatment Trial (FACTT) fluid protocols.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a secondary cross-sectional analysis of the FACTT multi-center randomized controlled&#xD;
      trial enrolling adult patients within 48 hours of ARDS onset from twenty medical centers&#xD;
      across the US, some of which included more than one hospital. We studied the patients who&#xD;
      were randomized to the pulmonary artery catheter arm of the FACTT study. The investigators&#xD;
      included patients that had PEEP and cardiac index measurements performed within a short&#xD;
      period of each other during the first 3 days of the FACTT study enrollment. Since FACTT had a&#xD;
      2x2 factorial design, half of the patients were in a 'liberal fluids' study arm, and the&#xD;
      other half were in a 'conservative fluids' study arm.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2011</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiac Index</measure>
    <time_frame>Cross sectional (i.e. at time Zero only)</time_frame>
    <description>The cardiac index is a cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index.&#xD;
The cardiac index which is the outcome measure is assessed at the same time as the PEEP (which is the independent variable) is measured.&#xD;
The study participants are NOT followed for any period of time. This is a cross-sectional study design. Both variables (Cardiac index and PEEP) are measured at the same time.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">367</enrollment>
  <condition>Acute Respiratory Distress Syndrome (ARDS)</condition>
  <arm_group>
    <arm_group_label>High PEEP</arm_group_label>
    <description>Cohort of participants with positive end-expiratory pressure (PEEP) greater than or equal to 12cm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low PEEP</arm_group_label>
    <description>Cohort of participants with positive end-expiratory pressure (PEEP) less than 12cm.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        This is a secondary cross-sectional analysis of the FACTT multi-center randomized&#xD;
        controlled trial enrolling adult patients within 48 hours of ARDS onset from twenty medical&#xD;
        centers across the US, some of which included more than one hospital. We studied the&#xD;
        patients who were randomized to the pulmonary artery catheter arm of the FACTT study. We&#xD;
        included patients that had PEEP and cardiac index measurements performed within a short&#xD;
        period of each other during the first 3 days of the FACTT study enrollment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Acute lung injury diagnosis (as defined by The American - European Consensus Conference on&#xD;
        ARDS) of &lt; 48 hours in duration.&#xD;
&#xD;
        Patients in the Pulmonary Artery catheter (PAC) arm of the FACTT study. PaO2 / FiO2 ratio&#xD;
        of &lt; 200. Data from the first 3 days of mechanical ventilation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Select chronic conditions that could independently influence survival (e.g., expected&#xD;
        6-month survival &lt; 50%) and / or ventilator weaning.&#xD;
&#xD;
        PEEP values missing. FiO2 values missing. PaO2 values missing. Cardiac index values missing&#xD;
        Pressors and / or inotropes requirement.&#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>Wassim H Fares, MD MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University, School of Medicine, Department of Internal Medicine, Section of Pulmonary and Critical Care Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale University, School of Medicine, Department of Internal Medicine, Section of Pulmonary and Critical Care Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>October 25, 2012</last_update_submitted>
  <last_update_submitted_qc>October 25, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 26, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mechanical ventilation</keyword>
  <keyword>ARDS</keyword>
  <keyword>acute lung injury</keyword>
  <keyword>cardiac function</keyword>
  <keyword>cardiac index</keyword>
  <keyword>heart-lung interaction</keyword>
  <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>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/NCT01714583
org study id: NHLBI T32 HL007106-34
nct id: NCT01714583
lead sponsor: 
collaborator: 
has dmc: No
The objective of this study is to evaluate the association between positive end-expiratory
      pressure (PEEP) setting and cardiac function, as measured by cardiac index, in patients with
      acute respiratory distress syndrome (ARDS) who were managed on the NHLBI ARDS Network Fluid
      and Catheter Treatment Trial (FACTT) fluid protocols.
This is a secondary cross-sectional analysis of the FACTT multi-center randomized controlled
      trial enrolling adult patients within 48 hours of ARDS onset from twenty medical centers
      across the US, some of which included more than one hospital. We studied the patients who
      were randomized to the pulmonary artery catheter arm of the FACTT study. The investigators
      included patients that had PEEP and cardiac index measurements performed within a short
      period of each other during the first 3 days of the FACTT study enrollment. Since FACTT had a
      2x2 factorial design, half of the patients were in a 'liberal fluids' study arm, and the
      other half were in a 'conservative fluids' study arm.
time perspective: Retrospective
measure: Cardiac Index
time frame: Cross sectional (i.e. at time Zero only)
description: The cardiac index is a cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index.
The cardiac index which is the outcome measure is assessed at the same time as the PEEP (which is the independent variable) is measured.
The study participants are NOT followed for any period of time. This is a cross-sectional study design. Both variables (Cardiac index and PEEP) are measured at the same time.
arm group label: High PEEP
description: Cohort of participants with positive end-expiratory pressure (PEEP) greater than or equal to 12cm.
arm group label: Low PEEP
description: Cohort of participants with positive end-expiratory pressure (PEEP) less than 12cm.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wassim H Fares, MD MSc
role: Principal Investigator
affiliation: Yale University, School of Medicine, Department of Internal Medicine, Section of Pulmonary and Critical Care Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury
mesh term: Syndrome