<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/NCT02224378</url>
  </required_header>
  <id_info>
    <org_study_id>4-2011-0686</org_study_id>
    <nct_id>NCT02224378</nct_id>
  </id_info>
  <brief_title>Prediction of Fluid Responsiveness in Atrial Fibrillation Patients Who Underwent Valvular Heart Surgery: Peep-induced Increase in Central Venous Pressure vs. Passive Leg Raising</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dynamic indices of preload depending on the heart-lung interaction require sinus rhythm and&#xD;
      cannot be applied to patients with atrial fibrillation. PEEP-induced increase in central&#xD;
      venous pressure (CVP) was shown to be a valid predictor of fluid responsiveness after cardiac&#xD;
      surgery in patients with sinus rhythm, and was speculated to be of value in patients with&#xD;
      rhythm other than sinus. The aim of this study is to assess the predictability of&#xD;
      PEEP-induced increase in CVP and passive leg raising (PLR)-induced changes in stroke volume&#xD;
      index (SVI) on fluid responsiveness in patients with atrial fibrillation following valvular&#xD;
      heart surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>fluid responsiveness</measure>
    <time_frame>1hr after arriving at ICU</time_frame>
    <description>ventilator peep setting was adjusted to 0cmH2O as baseline&#xD;
Then peep was increased to 10cmH2O for 5 min.&#xD;
We set peep to baseline 0cmH2O again, making patients to semirecumbent position following passive leg raising at 30 degree for 5 min.&#xD;
After that, 300 ml of hydroxyethyl starch 130/0.4 was infused in the supine position for 10-20 min and haemodynamic variables including SVI were assessed 5 min after completion of fluid challenge.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Valvular Heart Surgery</condition>
  <arm_group>
    <arm_group_label>peep induced CVP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>passive leg raising(PLR)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>peep induced CVP</intervention_name>
    <arm_group_label>peep induced CVP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>passive leg raising(PLR)</intervention_name>
    <arm_group_label>passive leg raising(PLR)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age ≥20&#xD;
&#xD;
          2. atrial fibrillation patients who underwent elective valvular heart surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. age &lt; 20&#xD;
&#xD;
          2. LV ejection fraction &lt; 40%&#xD;
&#xD;
          3. any pulmonary disease&#xD;
&#xD;
          4. end stage renal disease&#xD;
&#xD;
          5. high intrabdominal pressure patient&#xD;
&#xD;
          6. contraindication of passive leg raising&#xD;
&#xD;
          7. deep vein thrombosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Anesthesiology &amp; Pain Medicine, Yonsei university college of medicine</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>March 31, 2015</last_update_submitted>
  <last_update_submitted_qc>March 31, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 1, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>fluid responsiveness</keyword>
  <keyword>atrial fibrillation</keyword>
  <keyword>passive leg raising</keyword>
  <keyword>central venous pressure</keyword>
  <keyword>valvular heart surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</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/NCT02224378
org study id: 4-2011-0686
nct id: NCT02224378
lead sponsor: 
has dmc: No
Dynamic indices of preload depending on the heart-lung interaction require sinus rhythm and
      cannot be applied to patients with atrial fibrillation. PEEP-induced increase in central
      venous pressure (CVP) was shown to be a valid predictor of fluid responsiveness after cardiac
      surgery in patients with sinus rhythm, and was speculated to be of value in patients with
      rhythm other than sinus. The aim of this study is to assess the predictability of
      PEEP-induced increase in CVP and passive leg raising (PLR)-induced changes in stroke volume
      index (SVI) on fluid responsiveness in patients with atrial fibrillation following valvular
      heart surgery.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: fluid responsiveness
time frame: 1hr after arriving at ICU
description: ventilator peep setting was adjusted to 0cmH2O as baseline
Then peep was increased to 10cmH2O for 5 min.
We set peep to baseline 0cmH2O again, making patients to semirecumbent position following passive leg raising at 30 degree for 5 min.
After that, 300 ml of hydroxyethyl starch 130/0.4 was infused in the supine position for 10-20 min and haemodynamic variables including SVI were assessed 5 min after completion of fluid challenge.
arm group label: peep induced CVP
arm group type: Experimental
arm group label: passive leg raising(PLR)
arm group type: Active Comparator
intervention type: Procedure
intervention name: peep induced CVP
arm group label: peep induced CVP
intervention type: Procedure
intervention name: passive leg raising(PLR)
arm group label: passive leg raising(PLR)
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Atrial Fibrillation