<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/NCT02239705</url>
  </required_header>
  <id_info>
    <org_study_id>A02</org_study_id>
    <nct_id>NCT02239705</nct_id>
  </id_info>
  <brief_title>Mathematical Coupling of Data in Transpulmonary Thermodilution</brief_title>
  <official_title>Mathematical Coupling of Data Between Global-End Diastolic Volume Index and Cardiac Index Calculated by Edwards EV1000</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Foggia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Foggia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate whether cardiac output (CO) and global end&#xD;
      diastolic volume (GEDV) determined from the same thermodilution curve by EV1000 are&#xD;
      mathematically coupled during the infusion of fluid or inotropic agents in critically ill&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Some fundamental questions remain unanswered about the mathematical analysis of the&#xD;
      thermodilution curve and the physiological significance of the Global End Diastolic Volume (&#xD;
      GEDV ) .&#xD;
&#xD;
      The mathematical derivation of the Global End Diastolic Volume (GEDV) is intimately linked&#xD;
      with the Cardiac Output (CO), because EV1000, to calculate the GEDV, uses a formula in which&#xD;
      the CO is the term &quot;flow &quot; for both the calculations of Volume Thermal Intra Thoracic (ITTV)&#xD;
      and Lung Thermal volume (PTV) .&#xD;
&#xD;
      The clinical validation of GEDV as an index of preload has been substantially based on&#xD;
      measuring changes in GEDV and CO in response to the Fluid Challenge only in patients &quot;volume&#xD;
      responsive&quot;.&#xD;
&#xD;
      In this scenario, GEDV and CO may show a close correlation only on the basis of their&#xD;
      mathematical derivation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">November 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Cardiac Output</measure>
    <time_frame>Triplicate measurement in each subject before and 20 minutes after therapeutic infusion of fluids or vasopressor agents</time_frame>
    <description>To evaluate the change in cardiac function after therapeutic life-saving fluid resuscitation or vasopressor agent infusion, cardiac output will be assessed before and after 20 minutes starting infusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Global end diastolic volume</measure>
    <time_frame>Triplicate measurement in each subject before and 20 minutes after therapeutic infusion of fluids or vasopressor agents</time_frame>
    <description>To evaluate the change in cardiac function after therapeutic life-saving fluid resuscitation or vasopressor agent infusion, global end diastolic volume will be assessed before and after 20 minutes starting infusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change Left ventricular volume</measure>
    <time_frame>Before and 20 minutes after therapeutic infusion of fluids or vasopressor agents</time_frame>
    <description>To evaluate the change in cardiac function after therapeutic, life-saving fluid resuscitation or vasopressor agent infusion, Left ventricular volume measurement with echocardiography will be evaluated before and after 20 minutes starting infusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change Right ventricular volume</measure>
    <time_frame>Before and 20 minutes after therapeutic infusion of fluids or vasopressor agents</time_frame>
    <description>To evaluate the change in cardiac function after therapeutic life-saving fluid resuscitation or vasopressor agent infusion, Right Ventricular Volume measurement with echocardiography will be assessed before and after 20 minutes starting infusion.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Critical Illness</condition>
  <arm_group>
    <arm_group_label>Fluid challenge</arm_group_label>
    <description>Patients whose clinical conditions require bolus of fluids infusion to correct blood pressure and cardiac output</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Inotropic infusion</arm_group_label>
    <description>Patient whose clinical conditions require inotropic agents infusion to correct blood pressure and cardiac output</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Critically ill patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient admitted in the Intensive Care Department&#xD;
&#xD;
          -  patient monitored by EV1000 trans pulmonary device&#xD;
&#xD;
          -  Systolic blood pressure (SBP) less than 90 mm Hg or SBP Drop ≥ 40 mm Hg of normal&#xD;
&#xD;
          -  decision by 1 expert intensivist physician to initiate fluid resuscitation hospital&#xD;
             protocol or therapeutic infusion of vasopressor agent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  age less than 18&#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>Michele Dambrosio, Medic</last_name>
    <role>Study Chair</role>
    <affiliation>University of Foggia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Livio Tullo, Medic</last_name>
    <role>Study Director</role>
    <affiliation>University of Foggia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alberto Sciusco, medic</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Foggia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alberto Sciusco, Doctor</last_name>
    <phone>0039 329 0408320</phone>
    <email>albertsciusc@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ospedali Riuniti</name>
      <address>
        <city>Foggia</city>
        <state>FG</state>
        <zip>70100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <contact>
      <last_name>Mauro Salaris, Segretary</last_name>
      <phone>0881.732387</phone>
      <email>anestesia.rianimazione@unifg.it</email>
    </contact>
    <investigator>
      <last_name>Livio Tullo, Medic</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Michele Dambrosio, medic</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alberto Sciusco, medic</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <link>
    <url>http://www.anestesia.unifg.it/Segreteria-e-Contatti/179/</url>
    <description>Speciality school of anesthesia of University of Foggia</description>
  </link>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <last_update_submitted>September 11, 2014</last_update_submitted>
  <last_update_submitted_qc>September 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Foggia</investigator_affiliation>
    <investigator_full_name>Alberto Sciusco</investigator_full_name>
    <investigator_title>Medical doctor</investigator_title>
  </responsible_party>
  <keyword>Trans pulmonary thermodilution</keyword>
  <keyword>Hemodynamic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</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/NCT02239705
org study id: A02
nct id: NCT02239705
lead sponsor: 
has dmc: Yes
The purpose of this study is to investigate whether cardiac output (CO) and global end
      diastolic volume (GEDV) determined from the same thermodilution curve by EV1000 are
      mathematically coupled during the infusion of fluid or inotropic agents in critically ill
      patients.
Some fundamental questions remain unanswered about the mathematical analysis of the
      thermodilution curve and the physiological significance of the Global End Diastolic Volume (
      GEDV ) .

      The mathematical derivation of the Global End Diastolic Volume (GEDV) is intimately linked
      with the Cardiac Output (CO), because EV1000, to calculate the GEDV, uses a formula in which
      the CO is the term "flow " for both the calculations of Volume Thermal Intra Thoracic (ITTV)
      and Lung Thermal volume (PTV) .

      The clinical validation of GEDV as an index of preload has been substantially based on
      measuring changes in GEDV and CO in response to the Fluid Challenge only in patients "volume
      responsive".

      In this scenario, GEDV and CO may show a close correlation only on the basis of their
      mathematical derivation.
observational model: Case-Control
time perspective: Prospective
measure: Change in Cardiac Output
time frame: Triplicate measurement in each subject before and 20 minutes after therapeutic infusion of fluids or vasopressor agents
description: To evaluate the change in cardiac function after therapeutic life-saving fluid resuscitation or vasopressor agent infusion, cardiac output will be assessed before and after 20 minutes starting infusion.
measure: Change in Global end diastolic volume
time frame: Triplicate measurement in each subject before and 20 minutes after therapeutic infusion of fluids or vasopressor agents
description: To evaluate the change in cardiac function after therapeutic life-saving fluid resuscitation or vasopressor agent infusion, global end diastolic volume will be assessed before and after 20 minutes starting infusion.
measure: Change Left ventricular volume
time frame: Before and 20 minutes after therapeutic infusion of fluids or vasopressor agents
description: To evaluate the change in cardiac function after therapeutic, life-saving fluid resuscitation or vasopressor agent infusion, Left ventricular volume measurement with echocardiography will be evaluated before and after 20 minutes starting infusion.
measure: Change Right ventricular volume
time frame: Before and 20 minutes after therapeutic infusion of fluids or vasopressor agents
description: To evaluate the change in cardiac function after therapeutic life-saving fluid resuscitation or vasopressor agent infusion, Right Ventricular Volume measurement with echocardiography will be assessed before and after 20 minutes starting infusion.
arm group label: Fluid challenge
description: Patients whose clinical conditions require bolus of fluids infusion to correct blood pressure and cardiac output
arm group label: Inotropic infusion
description: Patient whose clinical conditions require inotropic agents infusion to correct blood pressure and cardiac output
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michele Dambrosio, Medic
role: Study Chair
affiliation: University of Foggia
last name: Livio Tullo, Medic
role: Study Director
affiliation: University of Foggia
last name: Alberto Sciusco, medic
role: Principal Investigator
affiliation: University of Foggia
last name: Alberto Sciusco, Doctor
phone: 0039 329 0408320
email: albertsciusc@gmail.com
facility: 
contact: 
investigator: 
investigator: 
investigator: 
country: Italy
url: http://www.anestesia.unifg.it/Segreteria-e-Contatti/179/
description: Speciality school of anesthesia of University of Foggia
responsible party type: Principal Investigator
investigator affiliation: University of Foggia
investigator full name: Alberto Sciusco
investigator title: Medical doctor
mesh term: Critical Illness