<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/NCT03002129</url>
  </required_header>
  <id_info>
    <org_study_id>FLEx study</org_study_id>
    <nct_id>NCT03002129</nct_id>
  </id_info>
  <brief_title>FLuid Responsiveness Prediction Using EXtra Systoles</brief_title>
  <official_title>FLuid Responsiveness Prediction Using EXtra Systoles</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medical Center Groningen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medical Center Groningen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, the investigators propose to investigate a novel technique for fluid&#xD;
      responsiveness prediction. It is based on the occurrence of an extra systole, which induces a&#xD;
      preload variation: Extra systoles are comprised by, first, the premature/ectopic beat with&#xD;
      decreased cardiac preload, then, the post-ectopic beat with moderately increased preload.&#xD;
&#xD;
      Consequently, the post ectopic beat is associated with a Frank-Starling curve right shift but&#xD;
      is otherwise a normal sinus beat. As such, the post-ectopic beat elucidates and predicts the&#xD;
      hemodynamic effect of increasing preload, i.e. giving fluids&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">June 26, 2017</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>fluid challenge response in stroke volume</measure>
    <time_frame>during operation</time_frame>
    <description>To investigate if post-ectopic induced changes in blood pressure before a fluid bolus (5 ml/kg) predicts the fluid induced change in cardiac stroke volume</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Coronary Artery Bypass Graft</condition>
  <arm_group>
    <arm_group_label>fluid challenge</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>fluid challenge</intervention_name>
    <description>At two pre-defined time points during the procedure, enrolled patients will receive a fluid bolus of 5 ml/kg during 5 minutes</description>
    <arm_group_label>fluid challenge</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients requiring elective CABG or OPCAB surgery&#xD;
&#xD;
          -  Patient's age ≥ 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  EF &lt; 35%&#xD;
&#xD;
          -  End stage kidney failure (defined by the need for haemodialysis)&#xD;
&#xD;
          -  Patients with atrial fibrillation or frequent and coupled extra systoles (e.g.&#xD;
             trigemini)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Universitu Medical Center Groningen</name>
      <address>
        <city>Groningen</city>
        <zip>9713EZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>May 15, 2018</last_update_submitted>
  <last_update_submitted_qc>May 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Center Groningen</investigator_affiliation>
    <investigator_full_name>Prof.dr.T.W.L.Scheeren</investigator_full_name>
    <investigator_title>prof.dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiac Complexes, Premature</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03002129
org study id: FLEx study
nct id: NCT03002129
lead sponsor: 
has dmc: No
In this study, the investigators propose to investigate a novel technique for fluid
      responsiveness prediction. It is based on the occurrence of an extra systole, which induces a
      preload variation: Extra systoles are comprised by, first, the premature/ectopic beat with
      decreased cardiac preload, then, the post-ectopic beat with moderately increased preload.

      Consequently, the post ectopic beat is associated with a Frank-Starling curve right shift but
      is otherwise a normal sinus beat. As such, the post-ectopic beat elucidates and predicts the
      hemodynamic effect of increasing preload, i.e. giving fluids
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: fluid challenge response in stroke volume
time frame: during operation
description: To investigate if post-ectopic induced changes in blood pressure before a fluid bolus (5 ml/kg) predicts the fluid induced change in cardiac stroke volume
arm group label: fluid challenge
arm group type: Other
intervention type: Other
intervention name: fluid challenge
description: At two pre-defined time points during the procedure, enrolled patients will receive a fluid bolus of 5 ml/kg during 5 minutes
arm group label: fluid challenge
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: University Medical Center Groningen
investigator full name: Prof.dr.T.W.L.Scheeren
investigator title: prof.dr.
mesh term: Cardiac Complexes, Premature
sharing ipd: No