<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/NCT03753672</url>
  </required_header>
  <id_info>
    <org_study_id>2017-A03578-45</org_study_id>
    <nct_id>NCT03753672</nct_id>
  </id_info>
  <brief_title>Central Venous Pressure (CVP) Changes do Not Predict Preload Unresponsiveness</brief_title>
  <official_title>Central Venous Pressure (CVP) Changes do Not Predict Preload Unresponsiveness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hopital Antoine Beclere</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hopital Antoine Beclere</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>
      Passive leg raising (PLR) is routinely used to predict preload responsiveness in critically&#xD;
      ill patients. However, real-time measurements of cardiac output are required to assess its&#xD;
      effects. Some authors have suggested that in fluid non-responders, central venous pressure&#xD;
      (CVP) increased markedly. By analogy with the CVP rules proposed by Weill et al to assess a&#xD;
      fluid challenge, it has been hypothesized that an increase in CVP ≥ 5 mmHg during PLR can&#xD;
      predict preload unresponsiveness.&#xD;
&#xD;
      Objective Investigation of whether an increase in CVP ≥ 5 mmHg during PLR predict preload&#xD;
      unresponsiveness diagnosed by the absence of increase in velocity-time integral (VTI) of the&#xD;
      flow in the left ventricular outflow tract by more than 10% (4).&#xD;
&#xD;
      Methods Critically ill patients with a central venous catheter in place and for whom the&#xD;
      physician decided to test preload responsiveness by PLR were prospectively included.&#xD;
      Transthoracic echocardiography was performed to obtain VTI. The CVP and VTI were measured&#xD;
      before and during PLR.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 10, 2017</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Anticipated">March 2019</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 predictive value of changes in CVP to determine preload responsiveness</measure>
    <time_frame>ONE MINUTE TEST</time_frame>
    <description>Systolic, diastolic and mean arterial pressure will be assessed before and after the PLR test</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Cardiovascular Shock</condition>
  <arm_group>
    <arm_group_label>preload responsive</arm_group_label>
    <description>defined as an increase in Velocity time integral of the sub-aortic flow greater or equal to 10%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>preload unresponsive</arm_group_label>
    <description>defined as an increase in Velocity time integral of the sub-aortic flow lower than 10%</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>preload responsiveness</intervention_name>
    <description>We investigated whether an increase in CVP ≥ 5 mmHg during PLR predict preload unresponsiveness diagnosed by the absence of increase in velocity-time integral (VTI) of the flow in the left ventricular outflow tract by more than 10%</description>
    <arm_group_label>preload responsive</arm_group_label>
    <arm_group_label>preload unresponsive</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Critically ill patients with a central venous catheter in place and for whom the physician&#xD;
        decided to test preload responsiveness by PLR were prospectively included. Transthoracic&#xD;
        echocardiography was performed to obtain VTI. The CVP and VTI were measured before and&#xD;
        during PLR.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ADULTS&#xD;
&#xD;
          -  Patients presenting with shock or other signs of circulatory failure (tachycardia,&#xD;
             oliguria)&#xD;
&#xD;
          -  Need for the physician to test preload responsiveness&#xD;
&#xD;
          -  Patients already equipped by a central venous catheter for the measurement of CVP&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients&lt;18 years old&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  instaility justifying rapid increase in cathecolamines&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hamzaoui Olfa</name>
      <address>
        <city>Clamart</city>
        <zip>92141</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>OLFA HAMZAOUI, MD</last_name>
      <phone>0033145374957</phone>
      <email>olfa.hamzaoui@abc.aphp.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>February 21, 2019</last_update_submitted>
  <last_update_submitted_qc>February 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hopital Antoine Beclere</investigator_affiliation>
    <investigator_full_name>Hamzaoui Olfa</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shock, Cardiogenic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03753672
org study id: 2017-A03578-45
nct id: NCT03753672
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Passive leg raising (PLR) is routinely used to predict preload responsiveness in critically
      ill patients. However, real-time measurements of cardiac output are required to assess its
      effects. Some authors have suggested that in fluid non-responders, central venous pressure
      (CVP) increased markedly. By analogy with the CVP rules proposed by Weill et al to assess a
      fluid challenge, it has been hypothesized that an increase in CVP ≥ 5 mmHg during PLR can
      predict preload unresponsiveness.

      Objective Investigation of whether an increase in CVP ≥ 5 mmHg during PLR predict preload
      unresponsiveness diagnosed by the absence of increase in velocity-time integral (VTI) of the
      flow in the left ventricular outflow tract by more than 10% (4).

      Methods Critically ill patients with a central venous catheter in place and for whom the
      physician decided to test preload responsiveness by PLR were prospectively included.
      Transthoracic echocardiography was performed to obtain VTI. The CVP and VTI were measured
      before and during PLR.
observational model: Cohort
time perspective: Prospective
measure: the predictive value of changes in CVP to determine preload responsiveness
time frame: ONE MINUTE TEST
description: Systolic, diastolic and mean arterial pressure will be assessed before and after the PLR test
arm group label: preload responsive
description: defined as an increase in Velocity time integral of the sub-aortic flow greater or equal to 10%
arm group label: preload unresponsive
description: defined as an increase in Velocity time integral of the sub-aortic flow lower than 10%
intervention type: Diagnostic Test
intervention name: preload responsiveness
description: We investigated whether an increase in CVP ≥ 5 mmHg during PLR predict preload unresponsiveness diagnosed by the absence of increase in velocity-time integral (VTI) of the flow in the left ventricular outflow tract by more than 10%
arm group label: preload responsive
arm group label: preload unresponsive
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Hopital Antoine Beclere
investigator full name: Hamzaoui Olfa
investigator title: principal investigator
mesh term: Shock, Cardiogenic
sharing ipd: Undecided