<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/NCT03780660</url>
  </required_header>
  <id_info>
    <org_study_id>2017_60</org_study_id>
    <secondary_id>2018-A01449-46</secondary_id>
    <nct_id>NCT03780660</nct_id>
  </id_info>
  <brief_title>Diagnostic Accuracy of the Central Venous Pressure (CVP) Variation to Predict Fluid Responsiveness in Spontaneously Breathing Patients</brief_title>
  <acronym>VPVC</acronym>
  <official_title>Diagnostic Accuracy of the Central Venous Pressure (CVP) Variation to Predict Fluid Responsiveness in Spontaneously Breathing Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Volume expansion (VE) is often administered in intensive care (ICU)-patient to improve&#xD;
      arterial oxygen delivery. Such effect is secondary to an increase in stroke volume and&#xD;
      cardiac output. However, cardiac output increase in response to VE (fluid responsiveness)&#xD;
      only occurs when the heart is preload-dependant. Increasing evidence of the deleterious&#xD;
      effects of inappropriate fluid administration encourages the development of variables&#xD;
      predicting fluid responsiveness, but few have been validated in spontaneously breathing&#xD;
      patients.&#xD;
&#xD;
      Central venous pressure (CVP) variation in spontaneously patients during standardized or&#xD;
      unstandardized inspiratory maneuver may represent an easy tool to predict fluid&#xD;
      responsiveness. The hypothesise is that inspiratory maneuver may increase CVP variation in&#xD;
      fluid responsiveness patient whereas no or few variation may reflect fluid unresponsiveness.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 5, 2019</start_date>
  <completion_date type="Anticipated">February 2021</completion_date>
  <primary_completion_date type="Anticipated">February 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>the area under the ROC curve of the &quot;CVPV-st&quot; parameter</measure>
    <time_frame>an average 60 - 90 minute during the procedure</time_frame>
    <description>Diagnostic accuracy of the CVPV during a standardized inspiratory maneuver (CVPV-st) to predict fluid responsiveness.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the area under the ROC curve of the &quot;CVPV-un&quot; parameter</measure>
    <time_frame>an average 60 - 90 minute during the procedure</time_frame>
    <description>Diagnostic accuracy of the CVPV during an unstandardized inspiratory maneuver (CVPV-un) to predict fluid responsiveness.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">68</enrollment>
  <condition>Breathing</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patient hospitalized in one of intensive care unit of Roger Salengro university hospital&#xD;
        CHU Lille&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Spontaneous breathing without mechanical assistance&#xD;
&#xD;
          -  Central venous catheter (superior vena cava) and monitoring of central venous pressure&#xD;
&#xD;
          -  Urinary catheter and monitoring of intra-abdominal pressure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intolerance to ventilatory manœuvre including Severe basal dyspnea/Symptomatic heart&#xD;
             failure (pulmonary edema)&#xD;
&#xD;
          -  Contraindication to passive leg raising (intracranial hypertension)&#xD;
&#xD;
          -  Passive leg raising unsuitable for measuring hemodynamic response : High grade aortic&#xD;
             insufficiency/ Poor echogenicity unsuitable to measure the velocity-time /integral of&#xD;
             aortic blood flow/ Pregnancy/Abdominal hypertension with abdominal compartment&#xD;
             syndrome/ Lower leg amputation&#xD;
&#xD;
          -  Necessity of urgent hemodynamic therapy (within 90 min)&#xD;
&#xD;
          -  Modification of hemodynamic therapy during study protocol (vascular filling, increase&#xD;
             catecholamine dose&#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>Sébastien Preau, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sébastien Preau, MD</last_name>
    <phone>03.20.44.44.95</phone>
    <phone_ext>+33</phone_ext>
    <email>sebastien.preau@chru-lille.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hôpital Roger Salengro, CHU</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Sébastien Preau, MD,PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>September 10, 2020</last_update_submitted>
  <last_update_submitted_qc>September 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Volume expansion</keyword>
  <keyword>fluid responsiveness</keyword>
  <keyword>critically ill patient</keyword>
  <keyword>spontaneously breathing patient</keyword>
  <keyword>central venous pressure variation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Aspiration</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/NCT03780660
org study id: 2017_60
secondary id: 2018-A01449-46
nct id: NCT03780660
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Volume expansion (VE) is often administered in intensive care (ICU)-patient to improve
      arterial oxygen delivery. Such effect is secondary to an increase in stroke volume and
      cardiac output. However, cardiac output increase in response to VE (fluid responsiveness)
      only occurs when the heart is preload-dependant. Increasing evidence of the deleterious
      effects of inappropriate fluid administration encourages the development of variables
      predicting fluid responsiveness, but few have been validated in spontaneously breathing
      patients.

      Central venous pressure (CVP) variation in spontaneously patients during standardized or
      unstandardized inspiratory maneuver may represent an easy tool to predict fluid
      responsiveness. The hypothesise is that inspiratory maneuver may increase CVP variation in
      fluid responsiveness patient whereas no or few variation may reflect fluid unresponsiveness.
observational model: Cohort
time perspective: Prospective
measure: the area under the ROC curve of the "CVPV-st" parameter
time frame: an average 60 - 90 minute during the procedure
description: Diagnostic accuracy of the CVPV during a standardized inspiratory maneuver (CVPV-st) to predict fluid responsiveness.
measure: the area under the ROC curve of the "CVPV-un" parameter
time frame: an average 60 - 90 minute during the procedure
description: Diagnostic accuracy of the CVPV during an unstandardized inspiratory maneuver (CVPV-un) to predict fluid responsiveness.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sébastien Preau, MD
role: Principal Investigator
affiliation: University Hospital, Lille
last name: Sébastien Preau, MD
phone: 03.20.44.44.95
phone ext: +33
email: sebastien.preau@chru-lille.fr
facility: 
status: Recruiting
investigator: 
country: France
responsible party type: Sponsor
mesh term: Respiratory Aspiration