<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/NCT03834675</url>
  </required_header>
  <id_info>
    <org_study_id>PICC -CICC for TPTD</org_study_id>
    <nct_id>NCT03834675</nct_id>
  </id_info>
  <brief_title>Suitability of PICC for Transpulmonary Thermodilution Compared to CICC</brief_title>
  <official_title>Are Peripherally Inserted Central Catheters (PICC) Suitable for Cardiac Output Assessment With Trans-pulmonary Thermodilution</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Claudio Sandroni</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sofia Cacciola</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Antonio Maria Dell Anna</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mauro Pittiruti</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Maria Giuseppina Annetta</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cesare Colosimo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Massimo Antonelli</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</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>
      Peripherally inserted central catheters (PICCs) are increasingly used in intensive care unit&#xD;
      (ICU) as an alternative to centrally inserted central catheters (CICCs) for intravenous&#xD;
      infusion. In the present study we try to assess their reliability for measuring cardiac index&#xD;
      (CI) with trans-pulmonary thermodilution (TPTD) technique.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">January 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiac Index comparison via PICC</measure>
    <time_frame>One hour</time_frame>
    <description>comparison of hemodynamic measurements made by the TPTD from the VolumeView/EV1000TM system via PICC vs. CICC.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison 4Fr PICCs to CICC</measure>
    <time_frame>one hour</time_frame>
    <description>Comparison of single-lumen 4 Fr PICCs to CICC in their reliability of assessing cardiac output</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison 5Fr PICCs to CICC</measure>
    <time_frame>one hour</time_frame>
    <description>Comparison of dual-lumen 5 Fr PICCs to CICC in their reliability of assessing cardiac output</description>
  </secondary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Peripherally Inserted Central Catheters</condition>
  <condition>CVC</condition>
  <condition>Transpulmonary Thermodilution</condition>
  <condition>Hemodynamic Monitoring</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>transpulmonary thermodilution</intervention_name>
    <description>Thermodilution was attempted via PICC and via CICC</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients (≥18 years) admitted to the ICU&#xD;
&#xD;
          -  Patients requiring hemodynamic monitoring using EV1000TM&#xD;
&#xD;
          -  Patients having both PICC and CICC in place (these patients had their PICC replaced&#xD;
             with a CICC, usually at the time of ICU admission, or vice versa, usually at the end&#xD;
             of their ICU stay, and were enrolled immediately after the placement of the new device&#xD;
             before the previous one was removed)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  body weight &lt;40 kg&#xD;
&#xD;
          -  severe aortic regurgitation or intra-cardiac shunt&#xD;
&#xD;
          -  treatment with an intra-aortic balloon pump&#xD;
&#xD;
          -  contraindication for placement of PICC, CICC or a femoral arterial catheter&#xD;
&#xD;
          -  abdominal aneurism&#xD;
&#xD;
          -  extracorporeal circulation&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  lack of informed consent&#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>Massimo Antonelli, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Università Cattolica del sacro Cuore- Fondazione Policlinico Universitario A. Gemelli IRCSS</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario A. Gemelli IRCCS</name>
      <address>
        <city>Roma</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>January 22, 2020</last_update_submitted>
  <last_update_submitted_qc>January 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</investigator_affiliation>
    <investigator_full_name>Dr.ssa Sonia D'Arrigo</investigator_full_name>
    <investigator_title>Medical Doctor - PhD</investigator_title>
  </responsible_party>
  <keyword>PICC</keyword>
  <keyword>shock</keyword>
  <keyword>cardiac output</keyword>
  <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/NCT03834675
org study id: PICC -CICC for TPTD
nct id: NCT03834675
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Peripherally inserted central catheters (PICCs) are increasingly used in intensive care unit
      (ICU) as an alternative to centrally inserted central catheters (CICCs) for intravenous
      infusion. In the present study we try to assess their reliability for measuring cardiac index
      (CI) with trans-pulmonary thermodilution (TPTD) technique.
intervention model: Crossover Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Cardiac Index comparison via PICC
time frame: One hour
description: comparison of hemodynamic measurements made by the TPTD from the VolumeView/EV1000TM system via PICC vs. CICC.
measure: Comparison 4Fr PICCs to CICC
time frame: one hour
description: Comparison of single-lumen 4 Fr PICCs to CICC in their reliability of assessing cardiac output
measure: Comparison 5Fr PICCs to CICC
time frame: one hour
description: Comparison of dual-lumen 5 Fr PICCs to CICC in their reliability of assessing cardiac output
intervention type: Diagnostic Test
intervention name: transpulmonary thermodilution
description: Thermodilution was attempted via PICC and via CICC
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Massimo Antonelli, MD
role: Study Chair
affiliation: Università Cattolica del sacro Cuore- Fondazione Policlinico Universitario A. Gemelli IRCSS
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
investigator full name: Dr.ssa Sonia D'Arrigo
investigator title: Medical Doctor - PhD
sharing ipd: Undecided