<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/NCT03012919</url>
  </required_header>
  <id_info>
    <org_study_id>1967/2014</org_study_id>
    <nct_id>NCT03012919</nct_id>
  </id_info>
  <brief_title>Evaluation of an Active Decision Support System for Hemodynamic Optimization During High Risk Vascular Surgery</brief_title>
  <official_title>Evaluation of an Active Decision Support System for Hemodynamic Optimization During High Risk Vascular Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</source>
  <brief_summary>
    <textblock>
      Rivers et al. laid the foundation for modern hemodynamic and fluid management by establishing&#xD;
      goal directed therapy (GDT) for the treatment of sepsis using fluid and inotropic and&#xD;
      vasoactive agents. There have been many subsequent protocols to improve outcome in the&#xD;
      operating room or in the ICU. These are mainly passive decision support systems. Active&#xD;
      clinical decision support systems using fluid and pharmacologic agents to improve&#xD;
      intraoperative hemodynamics are not really found.&#xD;
&#xD;
      The investigators developed an active clinical decision support system based on an&#xD;
      institutional GDT-protocol using fluid, vasopressors and inotropes using the LiDCOrapid&#xD;
      device.&#xD;
&#xD;
      The goal of the study was to check the feasibility of an active clinical decision support&#xD;
      system to optimize hemodynamics during high risk vascular surgery based on the principles of&#xD;
      GDT implementing fluid, vasopressors and inotropes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2015</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>number of interventions done according to the active decision support system (GDT protocol)</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>The number of interventions done according to the active decision support system (GDT protocol) is calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>duration of use of active decision support system</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>The absolute duration of use and relative duration of use (in relation to the duration of surgery) of the active decision support system are calculated.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Feasibility</condition>
  <condition>Active Decision Support System</condition>
  <condition>Goal Directed Therapy</condition>
  <arm_group>
    <arm_group_label>active decision support system (GDT protocol)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The active decision support system in this study is a goal directed therapy (GDT) protocol where threshold hemodynamic values are defined when to give fluid, vasopressors and inotropes. Hemodynamic values are measured with the LiDCOrapid device, which uses pulse contour analysis to continuously monitor cardiac output and respiratory variations in stroke volume (SVV).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>active decision support system</intervention_name>
    <description>The active decision support system in this study is a goal directed therapy (GDT) protocol where threshold hemodynamic values are defined when to give fluid, vasopressors and inotropes. Hemodynamic values are measured with the LiDCOrapid device, which uses pulse contour analysis to continuously monitor cardiac output and respiratory variations in stroke volume (SVV).</description>
    <arm_group_label>active decision support system (GDT protocol)</arm_group_label>
    <other_name>goal directed therapy (GDT) protocol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  elective major vascular surgery such as peripheral arterial surgery and open abdominal&#xD;
             aortic surgery except for carotid artery surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients under 18 years of age&#xD;
&#xD;
          -  absence of cardiac sinus rhythm at induction of anesthesia&#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>Martin Dworschak, Prof. Dr.</last_name>
    <role>Study Director</role>
    <affiliation>Medical University of Vienna</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael Hiesmayr, Prof. Dr.</last_name>
    <role>Study Director</role>
    <affiliation>Medical University of Vienna</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Johannes Menger, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Vienna</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Arabella Fischer, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Vienna</affiliation>
  </overall_official>
  <reference>
    <citation>Fitzgerald M, Cameron P, Mackenzie C, Farrow N, Scicluna P, Gocentas R, Bystrzycki A, Lee G, O'Reilly G, Andrianopoulos N, Dziukas L, Cooper DJ, Silvers A, Mori A, Murray A, Smith S, Xiao Y, Stub D, McDermott FT, Rosenfeld JV. Trauma resuscitation errors and computer-assisted decision support. Arch Surg. 2011 Feb;146(2):218-25. doi: 10.1001/archsurg.2010.333.</citation>
    <PMID>21339436</PMID>
  </reference>
  <reference>
    <citation>Feldheiser A, Conroy P, Bonomo T, Cox B, Garces TR, Spies C; Anaesthesia Working Group of the Enhanced Recovery After Surgery (ERAS(R)) Society; Enhanced Recovery After Surgery Society. Development and feasibility study of an algorithm for intraoperative goaldirected haemodynamic management in noncardiac surgery. J Int Med Res. 2012;40(4):1227-41. doi: 10.1177/147323001204000402.</citation>
    <PMID>22971475</PMID>
  </reference>
  <reference>
    <citation>Sondergaard S, Wall P, Cocks K, Parkin WG, Leaning MS. High concordance between expert anaesthetists' actions and advice of decision support system in achieving oxygen delivery targets in high-risk surgery patients. Br J Anaesth. 2012 Jun;108(6):966-72. doi: 10.1093/bja/aes037. Epub 2012 Mar 16.</citation>
    <PMID>22427342</PMID>
  </reference>
  <reference>
    <citation>Sahota N, Lloyd R, Ramakrishna A, Mackay JA, Prorok JC, Weise-Kelly L, Navarro T, Wilczynski NL, Haynes RB; CCDSS Systematic Review Team. Computerized clinical decision support systems for acute care management: a decision-maker-researcher partnership systematic review of effects on process of care and patient outcomes. Implement Sci. 2011 Aug 3;6:91. doi: 10.1186/1748-5908-6-91.</citation>
    <PMID>21824385</PMID>
  </reference>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>December 30, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>June 17, 2017</last_update_submitted>
  <last_update_submitted_qc>June 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Arabella Fischer, MD</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>active decision support system</keyword>
  <keyword>goal directed therapy</keyword>
  <keyword>Lidco</keyword>
  <keyword>vascular surgery</keyword>
  <keyword>hemodynamic optimization</keyword>
  <!-- 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/NCT03012919
org study id: 1967/2014
nct id: NCT03012919
lead sponsor: 
Rivers et al. laid the foundation for modern hemodynamic and fluid management by establishing
      goal directed therapy (GDT) for the treatment of sepsis using fluid and inotropic and
      vasoactive agents. There have been many subsequent protocols to improve outcome in the
      operating room or in the ICU. These are mainly passive decision support systems. Active
      clinical decision support systems using fluid and pharmacologic agents to improve
      intraoperative hemodynamics are not really found.

      The investigators developed an active clinical decision support system based on an
      institutional GDT-protocol using fluid, vasopressors and inotropes using the LiDCOrapid
      device.

      The goal of the study was to check the feasibility of an active clinical decision support
      system to optimize hemodynamics during high risk vascular surgery based on the principles of
      GDT implementing fluid, vasopressors and inotropes.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: number of interventions done according to the active decision support system (GDT protocol)
time frame: through study completion, an average of 6 months
description: The number of interventions done according to the active decision support system (GDT protocol) is calculated.
measure: duration of use of active decision support system
time frame: through study completion, an average of 6 months
description: The absolute duration of use and relative duration of use (in relation to the duration of surgery) of the active decision support system are calculated.
arm group label: active decision support system (GDT protocol)
arm group type: Other
description: The active decision support system in this study is a goal directed therapy (GDT) protocol where threshold hemodynamic values are defined when to give fluid, vasopressors and inotropes. Hemodynamic values are measured with the LiDCOrapid device, which uses pulse contour analysis to continuously monitor cardiac output and respiratory variations in stroke volume (SVV).
intervention type: Other
intervention name: active decision support system
description: The active decision support system in this study is a goal directed therapy (GDT) protocol where threshold hemodynamic values are defined when to give fluid, vasopressors and inotropes. Hemodynamic values are measured with the LiDCOrapid device, which uses pulse contour analysis to continuously monitor cardiac output and respiratory variations in stroke volume (SVV).
arm group label: active decision support system (GDT protocol)
other name: goal directed therapy (GDT) protocol
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Martin Dworschak, Prof. Dr.
role: Study Director
affiliation: Medical University of Vienna
last name: Michael Hiesmayr, Prof. Dr.
role: Study Director
affiliation: Medical University of Vienna
last name: Johannes Menger, Dr.
role: Principal Investigator
affiliation: Medical University of Vienna
last name: Arabella Fischer, Dr.
role: Principal Investigator
affiliation: Medical University of Vienna
citation: Fitzgerald M, Cameron P, Mackenzie C, Farrow N, Scicluna P, Gocentas R, Bystrzycki A, Lee G, O'Reilly G, Andrianopoulos N, Dziukas L, Cooper DJ, Silvers A, Mori A, Murray A, Smith S, Xiao Y, Stub D, McDermott FT, Rosenfeld JV. Trauma resuscitation errors and computer-assisted decision support. Arch Surg. 2011 Feb;146(2):218-25. doi: 10.1001/archsurg.2010.333.
PMID: 21339436
citation: Feldheiser A, Conroy P, Bonomo T, Cox B, Garces TR, Spies C; Anaesthesia Working Group of the Enhanced Recovery After Surgery (ERAS(R)) Society; Enhanced Recovery After Surgery Society. Development and feasibility study of an algorithm for intraoperative goaldirected haemodynamic management in noncardiac surgery. J Int Med Res. 2012;40(4):1227-41. doi: 10.1177/147323001204000402.
PMID: 22971475
citation: Sondergaard S, Wall P, Cocks K, Parkin WG, Leaning MS. High concordance between expert anaesthetists' actions and advice of decision support system in achieving oxygen delivery targets in high-risk surgery patients. Br J Anaesth. 2012 Jun;108(6):966-72. doi: 10.1093/bja/aes037. Epub 2012 Mar 16.
PMID: 22427342
citation: Sahota N, Lloyd R, Ramakrishna A, Mackay JA, Prorok JC, Weise-Kelly L, Navarro T, Wilczynski NL, Haynes RB; CCDSS Systematic Review Team. Computerized clinical decision support systems for acute care management: a decision-maker-researcher partnership systematic review of effects on process of care and patient outcomes. Implement Sci. 2011 Aug 3;6:91. doi: 10.1186/1748-5908-6-91.
PMID: 21824385
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Arabella Fischer, MD
investigator title: Dr.