<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/NCT02248025</url>
  </required_header>
  <id_info>
    <org_study_id>EudraCT/ANSM: 2014-A01034-43</org_study_id>
    <nct_id>NCT02248025</nct_id>
  </id_info>
  <brief_title>Can Capillary Refill Time Variation During Passive Leg Raising Predict Fluid Responsiveness</brief_title>
  <official_title>Can Capillary Refill Time Variation Induced by Passive Leg Raising Predict Capillary Refill Time Variation After a Fluid Load in Patients With Circulatory Failure.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hopital Louis Pradel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hopital Louis Pradel</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fluid responsiveness in a context of circulatory failure can be assessed by different way.&#xD;
      Microcirculatory evaluation to assess fluid responsiveness could be interesting, but the&#xD;
      available device are expensive and the analysis are delayed. Capillary refill time (CRT) is&#xD;
      hampered by its variability. The investigators have developed a method to standardize the&#xD;
      pressure, the length of compression and a computerized analysis to calculate the capillary&#xD;
      refill time. This method enables accurate measure of CRT.&#xD;
&#xD;
      The investigators will study if CRT variation induced by a passive leg raising (PLR) can&#xD;
      predict CRT after a 500 ml Fluid Load.&#xD;
&#xD;
      About thirty patients in circulatory failure with a continuous cardiac output monitoring for&#xD;
      whom, the attending physician has decided a fluid load, will be included. hemodynamic&#xD;
      parameters (arterial pressure, venous pressure, cardiac output), metabolic parameters&#xD;
      (arterial and venous blood gas and lactate), microcirculatory parameters (assessed by&#xD;
      sublingual video-microscopy) and capillary refill time measured on the thorax and on the&#xD;
      gingival area will be recorded. Data collection will be made before and after a passive leg&#xD;
      raising and after a 500 ml fluid load of crystalloids.&#xD;
&#xD;
      Patients will be aposteriori sorted in two groups: responders and non responders, defined by&#xD;
      the reduction of CRT after the fluid load. The diagnosis ability of the CRT variation after&#xD;
      PLR to predict in which group each patient is classified will be investigate and receiver&#xD;
      operative characteristic curve will be built. These results will be compared to the metabolic&#xD;
      response, the macrocirculatory response, and the microcirculatory response.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</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>Capillary refill time response</measure>
    <time_frame>The period of inclusion last 45 minutes, the outcome will be assessed at the end of the 500 ml fluid load 45 minutes after the inclusion.</time_frame>
    <description>A reduction of about 30% of the capillary refill time after a 500 ml fluid load will defined responders.&#xD;
Evaluation of the diagnosis capacity of capillary refill time variation after passive leg raising to diagnose responders will be investigate.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiac output response.</measure>
    <time_frame>The period of inclusion last 45 minutes, the outcome will be assessed at the end of the 500 ml fluid load 45 minutes after the inclusion.</time_frame>
    <description>An increase of 15% of cardiac output after a 500 ml fluid load will define macrocirculatory responders.&#xD;
Evaluation of the diagnosis capacity of capillary refill time after passive leg raising to diagnose macrocirculatory responders will be investigate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microcirculatory response</measure>
    <time_frame>The period of inclusion last 45 minutes, the outcome will be assessed at the end of the 500 ml fluid load 45 minutes after the inclusion.</time_frame>
    <description>An increase of 15% of the proportion of perfused vessels or from 0.6 of the microcirculatory flow index assessed by videomicroscopy after a 500 ml fluid load will define microcirculatory responders.&#xD;
Evaluation of the diagnosis capacity of capillary refill time variation after passive leg raising to diagnose microcirculatory responders will be investigate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolic response</measure>
    <time_frame>The period of inclusion last 45 minutes, the outcome will be assessed at the end of the 500 ml fluid load 45 minutes after the inclusion.</time_frame>
    <description>An increase of 15% Oxygen consumption after a 500 ml fluid load will define metabolic responders.&#xD;
Evaluation of the diagnosis capacity of capillary refill time to diagnose metabolic responders after passive leg raising will be investigate.</description>
  </secondary_outcome>
  <enrollment type="Actual">34</enrollment>
  <condition>Circulatory Failure</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational study: No special intervention will be made.</intervention_name>
    <description>No special intervention will be made, only data will be collected before, and after a passive leg raising and a fluid challenge decided and performed by the attending physician.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient hospitalized in our intensive care unit who are in circulatory failure and for whom&#xD;
        the intensivist as decided to administer a 500 ml crystalloid infusion.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient is equipped with an arterial and a central venous catheter&#xD;
&#xD;
          -  Capillary refill time is measurable.&#xD;
&#xD;
          -  A cardiac output monitoring is available&#xD;
&#xD;
          -  A 500 ml fluid load as been prescribed by the intensivist in charge.&#xD;
&#xD;
          -  A circulatory failure is present defined as follow:&#xD;
&#xD;
        Patient treated with inotropic or vasoconstrictive drugs&#xD;
&#xD;
        OR&#xD;
&#xD;
        Patient presenting an hypotension defined by systolic arterial pressure less than 90 mmHg&#xD;
        or mean arterial pressure less than 70 mmHg or a drop 40 mmHg in case of previous&#xD;
        Hypertension.&#xD;
&#xD;
        WITH&#xD;
&#xD;
        tissue hypoperfusion defined by at least one of the following item:&#xD;
&#xD;
          -  Lactate &gt; 1 mmol/L&#xD;
&#xD;
          -  Capillary refill time &gt; 3 s&#xD;
&#xD;
          -  Blotch&#xD;
&#xD;
          -  Organ dysfunction due to the circulatory failure (oligo anuria, acute lung injury /&#xD;
             acute respiratory distress syndrome, encephalopathy)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant woman&#xD;
&#xD;
          -  Cardiogenic pulmonary edema&#xD;
&#xD;
          -  Circulatory support : extracorporal life support / extracorporal membrane oxygenator,&#xD;
             Thoratec, heart mate.&#xD;
&#xD;
          -  Moribund patient&#xD;
&#xD;
          -  Intra-abdominal hypertension&#xD;
&#xD;
          -  Lower limb amputation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hôpital Cardiologique Louis Pradel Service d'anesthésie réanimation</name>
      <address>
        <city>Bron</city>
        <zip>69500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>September 13, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>May 4, 2017</last_update_submitted>
  <last_update_submitted_qc>May 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hopital Louis Pradel</investigator_affiliation>
    <investigator_full_name>Matthias Jacquet-Lagrèze</investigator_full_name>
    <investigator_title>Dr Matthias Jacquet-Lagèze</investigator_title>
  </responsible_party>
  <keyword>Fluid responsiveness</keyword>
  <keyword>capillary refill time</keyword>
  <keyword>microcirculation</keyword>
  <keyword>circulatory failure</keyword>
  <keyword>passive leg raising</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shock</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/NCT02248025
org study id: EudraCT/ANSM: 2014-A01034-43
nct id: NCT02248025
lead sponsor: 
has dmc: No
Fluid responsiveness in a context of circulatory failure can be assessed by different way.
      Microcirculatory evaluation to assess fluid responsiveness could be interesting, but the
      available device are expensive and the analysis are delayed. Capillary refill time (CRT) is
      hampered by its variability. The investigators have developed a method to standardize the
      pressure, the length of compression and a computerized analysis to calculate the capillary
      refill time. This method enables accurate measure of CRT.

      The investigators will study if CRT variation induced by a passive leg raising (PLR) can
      predict CRT after a 500 ml Fluid Load.

      About thirty patients in circulatory failure with a continuous cardiac output monitoring for
      whom, the attending physician has decided a fluid load, will be included. hemodynamic
      parameters (arterial pressure, venous pressure, cardiac output), metabolic parameters
      (arterial and venous blood gas and lactate), microcirculatory parameters (assessed by
      sublingual video-microscopy) and capillary refill time measured on the thorax and on the
      gingival area will be recorded. Data collection will be made before and after a passive leg
      raising and after a 500 ml fluid load of crystalloids.

      Patients will be aposteriori sorted in two groups: responders and non responders, defined by
      the reduction of CRT after the fluid load. The diagnosis ability of the CRT variation after
      PLR to predict in which group each patient is classified will be investigate and receiver
      operative characteristic curve will be built. These results will be compared to the metabolic
      response, the macrocirculatory response, and the microcirculatory response.
observational model: Cohort
time perspective: Prospective
measure: Capillary refill time response
time frame: The period of inclusion last 45 minutes, the outcome will be assessed at the end of the 500 ml fluid load 45 minutes after the inclusion.
description: A reduction of about 30% of the capillary refill time after a 500 ml fluid load will defined responders.
Evaluation of the diagnosis capacity of capillary refill time variation after passive leg raising to diagnose responders will be investigate.
measure: Cardiac output response.
time frame: The period of inclusion last 45 minutes, the outcome will be assessed at the end of the 500 ml fluid load 45 minutes after the inclusion.
description: An increase of 15% of cardiac output after a 500 ml fluid load will define macrocirculatory responders.
Evaluation of the diagnosis capacity of capillary refill time after passive leg raising to diagnose macrocirculatory responders will be investigate.
measure: Microcirculatory response
time frame: The period of inclusion last 45 minutes, the outcome will be assessed at the end of the 500 ml fluid load 45 minutes after the inclusion.
description: An increase of 15% of the proportion of perfused vessels or from 0.6 of the microcirculatory flow index assessed by videomicroscopy after a 500 ml fluid load will define microcirculatory responders.
Evaluation of the diagnosis capacity of capillary refill time variation after passive leg raising to diagnose microcirculatory responders will be investigate.
measure: Metabolic response
time frame: The period of inclusion last 45 minutes, the outcome will be assessed at the end of the 500 ml fluid load 45 minutes after the inclusion.
description: An increase of 15% Oxygen consumption after a 500 ml fluid load will define metabolic responders.
Evaluation of the diagnosis capacity of capillary refill time to diagnose metabolic responders after passive leg raising will be investigate.
intervention type: Other
intervention name: Observational study: No special intervention will be made.
description: No special intervention will be made, only data will be collected before, and after a passive leg raising and a fluid challenge decided and performed by the attending physician.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Hopital Louis Pradel
investigator full name: Matthias Jacquet-Lagrèze
investigator title: Dr Matthias Jacquet-Lagèze
mesh term: Shock