<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/NCT01673230</url>
  </required_header>
  <id_info>
    <org_study_id>2012-A00364-39</org_study_id>
    <secondary_id>LOC/12-01</secondary_id>
    <nct_id>NCT01673230</nct_id>
  </id_info>
  <brief_title>Hemodynamic Indices Predictive of a Beneficial Response to Fluid Expansion in Case of Hemodynamic Failure After Cardiac Surgery With Altered Preoperative Ejection Fraction (LVEF≤45%)</brief_title>
  <acronym>ALTERVOL</acronym>
  <official_title>Hemodynamic Indices Predictive of a Beneficial Response to Fluid Expansion in Case of Hemodynamic Failure After Cardiac Surgery With Altered Preoperative Ejection Fraction (LVEF≤45%): Sensibility and Specificity of Respiratory Variations of Pulse Pressure (∆PP), Photoplethysmography (∆POP), Perfusion Index (PVI), Before and After Fluid Expansion.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</source>
  <brief_summary>
    <textblock>
      Low Cardiac Output Syndrome occurs frequently after cardiac surgery, especially when&#xD;
      pre-operative LVEF is altered (LVEF≤45%). The correction of hemodynamic failure requires&#xD;
      adapted treatments: fluid expansion and/or inotropic or vasoactive drugs. Predictive indices&#xD;
      of a response to fluid challenge may allow an earlier hemodynamic optimization, which has not&#xD;
      been showed until now when LVEF is altered.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measure of ∆PP, ∆POP, PVI and Cardiac index (CI)</measure>
    <time_frame>2 hours</time_frame>
    <description>To assess the sensibility and specificity of ∆PP, ∆POP, PVI, after fluid expansion in case of hemodynamic failure in the immediate post-operative period after cardiac surgery, when pre-operative LVEF is altered.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measure of Systolic, diastolic and mean arterial pressure (SAP, DAP, MAP), Central venous pressure (CVP) and wedge pressure.</measure>
    <time_frame>2 hours</time_frame>
    <description>Secondary objectives :&#xD;
Early optimization of hemodynamics after cardiac surgery,&#xD;
To determine optimal threshold for ∆PP, ∆POP and PVI,&#xD;
To compare dynamic (∆PP, ∆POP and PVI) with static (central venous pressure: CVP, wedge pressure) indices</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Ventricular Dysfunction</condition>
  <arm_group>
    <arm_group_label>Ventricular dysfunction</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>cardiac surgery for ventricular dysfunction</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cardiac surgery for ventricular dysfunction</intervention_name>
    <description>For each included patient during the immediate post operative period, hemodynamic variables will be recorded (continuous arterial pressure, ECG, photoplethysmographic curve, CVP, wedge pressure, respiratory pressure), at rest (proclive 45°), during fluid expansion (physiological saline).</description>
    <arm_group_label>Ventricular dysfunction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients &gt;18 years old in the immediate post-operative period after cardiac surgery&#xD;
&#xD;
          -  ASA 1 - 3&#xD;
&#xD;
          -  Pre-operative LVEF≤45%&#xD;
&#xD;
          -  Sedated with Ramsay score: 6&#xD;
&#xD;
          -  Mechanically ventilated with tidal volume at 8ml/kg, PEEP at 0mmHg, I/Eat 0,5&#xD;
&#xD;
          -  With hemodynamic failure: SAP≤90mmHg and/or inotropic or vasoactive drug started in&#xD;
             the operating room and/or clinical sign of shock and/or CI ≤2,3l/min/m2&#xD;
&#xD;
          -  Affiliation to Health Insurance&#xD;
&#xD;
          -  Consent form signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiac arrhythmia: frequent atrial or ventricular extra systoles, atrial fibrillation&#xD;
&#xD;
          -  Intracardiac shunt&#xD;
&#xD;
          -  Weight less than 50 kg&#xD;
&#xD;
          -  History of central nervous system illness&#xD;
&#xD;
          -  Pulmonary oedema (clinical and/or radiological and/or wedge pressure&gt;18mmHg)&#xD;
&#xD;
          -  Right ventricular failure suspected (CVP&gt; wedge pressure) or diagnosed (trans thoracic&#xD;
             and/or transesophageal echocardiography)&#xD;
&#xD;
          -  Acute kidney injury with oligoanuria&#xD;
&#xD;
          -  Severe post operative bleeding (chest tubes volume of &gt;200ml/h for 3 hours or more)&#xD;
&#xD;
          -  Severe hypoxia (PaO2/FIO2&lt; 100)&#xD;
&#xD;
          -  Administrative control (patient under guardianship or curatorship)&#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>patrick guinet</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rennes University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rennes University Hospital</name>
      <address>
        <city>Rennes</city>
        <state>Brittany</state>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <last_update_submitted>December 26, 2019</last_update_submitted>
  <last_update_submitted_qc>December 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ventricular Dysfunction</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/NCT01673230
org study id: 2012-A00364-39
secondary id: LOC/12-01
nct id: NCT01673230
lead sponsor: 
Low Cardiac Output Syndrome occurs frequently after cardiac surgery, especially when
      pre-operative LVEF is altered (LVEF≤45%). The correction of hemodynamic failure requires
      adapted treatments: fluid expansion and/or inotropic or vasoactive drugs. Predictive indices
      of a response to fluid challenge may allow an earlier hemodynamic optimization, which has not
      been showed until now when LVEF is altered.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Measure of ∆PP, ∆POP, PVI and Cardiac index (CI)
time frame: 2 hours
description: To assess the sensibility and specificity of ∆PP, ∆POP, PVI, after fluid expansion in case of hemodynamic failure in the immediate post-operative period after cardiac surgery, when pre-operative LVEF is altered.
measure: Measure of Systolic, diastolic and mean arterial pressure (SAP, DAP, MAP), Central venous pressure (CVP) and wedge pressure.
time frame: 2 hours
description: Secondary objectives :
Early optimization of hemodynamics after cardiac surgery,
To determine optimal threshold for ∆PP, ∆POP and PVI,
To compare dynamic (∆PP, ∆POP and PVI) with static (central venous pressure: CVP, wedge pressure) indices
arm group label: Ventricular dysfunction
arm group type: Other
description: cardiac surgery for ventricular dysfunction
intervention type: Procedure
intervention name: cardiac surgery for ventricular dysfunction
description: For each included patient during the immediate post operative period, hemodynamic variables will be recorded (continuous arterial pressure, ECG, photoplethysmographic curve, CVP, wedge pressure, respiratory pressure), at rest (proclive 45°), during fluid expansion (physiological saline).
arm group label: Ventricular dysfunction
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: patrick guinet
role: Principal Investigator
affiliation: Rennes University Hospital
facility: 
country: France
responsible party type: Sponsor
mesh term: Ventricular Dysfunction