<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/NCT01681758</url>
  </required_header>
  <id_info>
    <org_study_id>AICU2012-007</org_study_id>
    <nct_id>NCT01681758</nct_id>
  </id_info>
  <brief_title>An Assessment of Pulse Pressure Variation to Guide Fluid Therapy in Cardiac Surgery Patients</brief_title>
  <official_title>A Before-and-after Assessment of Pulse Pressure Variation Guided Fluid Therapy in Cardiac Surgery Patients Receiving Mandatory Mechanical Ventilation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Austin Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Austin Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We aim to test the hypothesis that fluid therapy based on pulse pressure variation (PPV) in&#xD;
      patients after cardiac surgery who are mechanically ventilated leads to a significant&#xD;
      decrease in the amount of fluid given to such patients in the first 24 hours after surgery&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. The investigators will study patients after cardiac surgery&#xD;
&#xD;
        2. The investigators will collect data on standard care in pre-intervention population&#xD;
&#xD;
        3. The investigators will collect demographic and clinical data&#xD;
&#xD;
        4. The investigators will collect biochemical data in the first 24 hours after surgery&#xD;
&#xD;
        5. The investigators will collect biochemical, physiological and clinical outcome data&#xD;
&#xD;
        6. The investigators will compare the standard care and intervention period data&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean amount of fluid given in the first 24 hours after surgery</measure>
    <time_frame>24 hours</time_frame>
    <description>all intravenous fluid administered</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physiological outcome</measure>
    <time_frame>24 hours</time_frame>
    <description>Blood lactate</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Physiological outcome</measure>
    <time_frame>24 hours</time_frame>
    <description>cardiac index</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">104</enrollment>
  <condition>Cardiac Surgery</condition>
  <arm_group>
    <arm_group_label>PPV</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>use PPV to guide fluid therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>standard care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>fluids according to standard care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>IV fluid according to PPV</intervention_name>
    <description>intravenous fluids</description>
    <arm_group_label>PPV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>fluids according to standard care</intervention_name>
    <arm_group_label>standard care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. immediately after ICU admission after cardiac surgery&#xD;
&#xD;
          2. mandatory mechanical ventilation -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pressure support ventilation&#xD;
&#xD;
          2. ECMO&#xD;
&#xD;
          3. Intra-aortic balloon counterpulsation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Austin Hospital</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3079</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>September 6, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>July 9, 2013</last_update_submitted>
  <last_update_submitted_qc>July 9, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 11, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Austin Health</investigator_affiliation>
    <investigator_full_name>Rinaldo Bellomo</investigator_full_name>
    <investigator_title>Director of ICU Research</investigator_title>
  </responsible_party>
  <keyword>cardiac surgery</keyword>
  <keyword>Pulse pressure variation</keyword>
  <keyword>intravenous fluids</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/NCT01681758
org study id: AICU2012-007
nct id: NCT01681758
lead sponsor: 
has dmc: No
We aim to test the hypothesis that fluid therapy based on pulse pressure variation (PPV) in
      patients after cardiac surgery who are mechanically ventilated leads to a significant
      decrease in the amount of fluid given to such patients in the first 24 hours after surgery
1. The investigators will study patients after cardiac surgery

        2. The investigators will collect data on standard care in pre-intervention population

        3. The investigators will collect demographic and clinical data

        4. The investigators will collect biochemical data in the first 24 hours after surgery

        5. The investigators will collect biochemical, physiological and clinical outcome data

        6. The investigators will compare the standard care and intervention period data
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean amount of fluid given in the first 24 hours after surgery
time frame: 24 hours
description: all intravenous fluid administered
measure: Physiological outcome
time frame: 24 hours
description: Blood lactate
measure: Physiological outcome
time frame: 24 hours
description: cardiac index
arm group label: PPV
arm group type: Active Comparator
description: use PPV to guide fluid therapy
arm group label: standard care
arm group type: Placebo Comparator
description: fluids according to standard care
intervention type: Other
intervention name: IV fluid according to PPV
description: intravenous fluids
arm group label: PPV
intervention type: Other
intervention name: fluids according to standard care
arm group label: standard care
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: Australia
responsible party type: Principal Investigator
investigator affiliation: Austin Health
investigator full name: Rinaldo Bellomo
investigator title: Director of ICU Research