<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/NCT01730820</url>
  </required_header>
  <id_info>
    <org_study_id>NEO CO</org_study_id>
    <secondary_id>A12-D20-VOL12</secondary_id>
    <nct_id>NCT01730820</nct_id>
  </id_info>
  <brief_title>Influence of Preload Dependence on the Effect of Phenylephrine on Cardiac Output</brief_title>
  <official_title>Influence of Preload Dependence on the Effect of Phenylephrine on Cardiac Output</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Caen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Caen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The perioperative hemodynamic management aims to ensure organ perfusion pressure and an&#xD;
      oxygen arterial transport adapted to oxygen consumption. Phenylephrine is the α-adrenergic&#xD;
      agonist widely used during anesthesia for arterial pressure control.&#xD;
&#xD;
      Several questions on phenylephrine global and regional hemodynamics effects remain&#xD;
      unresolved.&#xD;
&#xD;
      The investigators assume that Phenylephrine may decrease cardiac output by increasing the&#xD;
      afterload, while most likely could also make an increase or a stability of cardiac output by&#xD;
      action on the venous return. The investigators propose an observational study assessing the&#xD;
      influence of preload dependence, defined by the values of pulse pressure variation, on the&#xD;
      effect of phenylephrine on cardiac output, measured beat by beat by esophageal Doppler.&#xD;
&#xD;
      The aim of the investigators work is to improve the understanding of phenylephrine action, a&#xD;
      daily use therapeutic action, to improve the patients care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>cardiac output</measure>
    <time_frame>one year</time_frame>
    <description>Comparing cardiac output values before and after injection of a phenylephrine bolus, based on the existence of a preload dependency, defined by a measure of respiratory variation of pulse pressure greater than or equal to 13%.</description>
  </primary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Hypotension</condition>
  <eligibility>
    <study_pop>
      <textblock>
        General anesthesia.Orotracheal intubation and mechanical ventilation Advanced Hemodynamic&#xD;
        Monitoring intraoperative ( arterial pressure catheter, esophageal Doppler)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hypotension (SBP &lt;90 mm Hg and / or MAP &lt;60 mm Hg)&#xD;
&#xD;
          -  Injection of a bolus of phenylephrine at the discretion of the anesthesiologist&#xD;
             physician in charge of the patient.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minor or major patient under guardianship&#xD;
&#xD;
          -  Esophageal Diseases&#xD;
&#xD;
          -  supra ventricular rhythm trouble&#xD;
&#xD;
          -  Severe valvular&#xD;
&#xD;
          -  Shunt intracardiac&#xD;
&#xD;
          -  Vt &lt;7ml/kg theoretical weight&#xD;
&#xD;
          -  heart rate / respiratory rate &lt;3.6&#xD;
&#xD;
          -  Clinical hypepression of intra-abdominal&#xD;
&#xD;
          -  Compliance &lt;30 mL/cmH2O&#xD;
&#xD;
          -  pulmonary hypertension, Right ventricular failure&#xD;
&#xD;
          -  Spontaneous Ventilation&#xD;
&#xD;
          -  Thorax open&#xD;
&#xD;
          -  VG severe dysfunction (LVEF &lt;40%)&#xD;
&#xD;
          -  Prior Injection of ephedrine prior&#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>Olivier REBET, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Caen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CAEN University Hospital</name>
      <address>
        <city>Caen</city>
        <state>Basse Normandie</state>
        <zip>1400</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>November 16, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>September 12, 2014</last_update_submitted>
  <last_update_submitted_qc>September 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 15, 2014</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>Hypotension</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/NCT01730820
org study id: NEO CO
secondary id: A12-D20-VOL12
nct id: NCT01730820
lead sponsor: 
has dmc: Yes
The perioperative hemodynamic management aims to ensure organ perfusion pressure and an
      oxygen arterial transport adapted to oxygen consumption. Phenylephrine is the α-adrenergic
      agonist widely used during anesthesia for arterial pressure control.

      Several questions on phenylephrine global and regional hemodynamics effects remain
      unresolved.

      The investigators assume that Phenylephrine may decrease cardiac output by increasing the
      afterload, while most likely could also make an increase or a stability of cardiac output by
      action on the venous return. The investigators propose an observational study assessing the
      influence of preload dependence, defined by the values of pulse pressure variation, on the
      effect of phenylephrine on cardiac output, measured beat by beat by esophageal Doppler.

      The aim of the investigators work is to improve the understanding of phenylephrine action, a
      daily use therapeutic action, to improve the patients care.
time perspective: Prospective
measure: cardiac output
time frame: one year
description: Comparing cardiac output values before and after injection of a phenylephrine bolus, based on the existence of a preload dependency, defined by a measure of respiratory variation of pulse pressure greater than or equal to 13%.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Olivier REBET, M.D
role: Principal Investigator
affiliation: University Hospital, Caen
facility: 
country: France
responsible party type: Sponsor
mesh term: Hypotension