<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/NCT03023618</url>
  </required_header>
  <id_info>
    <org_study_id>PERILLI-NICE</org_study_id>
    <nct_id>NCT03023618</nct_id>
  </id_info>
  <brief_title>Fluid Oriented Therapy During Major Abdominal Surgery</brief_title>
  <official_title>Effect Of Stroke Volume Optimization On Complication Rate Of Patients Undergoing Pancreatic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this &quot;before and after&quot; study we will investigate the potential benefit on postoperative&#xD;
      outcomes of a guided fluid therapy with a stroke volume optimization . The NICE protocol has&#xD;
      been applied by means of EV1000 monitor and arterial waveform analysis ( Flotrac - Edwards).&#xD;
      In the postoperative period overall complications, as well as exitus , will be analyzed and&#xD;
      compared with those of a control group underwent the same surgical interventions, with a&#xD;
      standard hemodynamic monitoring.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>complication rate</measure>
    <time_frame>up to 30 days postoperatively</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of hospitalization</measure>
    <time_frame>an average of 30 days</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>amount of intraoperative fluids</measure>
    <time_frame>an average of 12 hours</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Goal Directed Therapy</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>patients before 2014, in which fluids were administered without FloTrac monitoring</description>
  </arm_group>
  <arm_group>
    <arm_group_label>case group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients after 2014, after management of fluid therapy has been guided by FloTrac parameters as a standard clinical practice (NICE protocol)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FloTrac</intervention_name>
    <description>Stroke Volume has been maintained at 90% of the maximal Stroke Volume as in NICE protocol 2011</description>
    <arm_group_label>case group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA 1-2 patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe Caridiac Disease&#xD;
&#xD;
          -  Renal Failure&#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>Valter MD Perilli, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesiology</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 1, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>January 17, 2017</last_update_submitted>
  <last_update_submitted_qc>January 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 18, 2017</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.Andrea Russo</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>[G09.330.380]</keyword>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03023618
org study id: PERILLI-NICE
nct id: NCT03023618
lead sponsor: 
has dmc: Yes
In this "before and after" study we will investigate the potential benefit on postoperative
      outcomes of a guided fluid therapy with a stroke volume optimization . The NICE protocol has
      been applied by means of EV1000 monitor and arterial waveform analysis ( Flotrac - Edwards).
      In the postoperative period overall complications, as well as exitus , will be analyzed and
      compared with those of a control group underwent the same surgical interventions, with a
      standard hemodynamic monitoring.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: complication rate
time frame: up to 30 days postoperatively
measure: Duration of hospitalization
time frame: an average of 30 days
measure: amount of intraoperative fluids
time frame: an average of 12 hours
arm group label: control group
arm group type: No Intervention
description: patients before 2014, in which fluids were administered without FloTrac monitoring
arm group label: case group
arm group type: Active Comparator
description: patients after 2014, after management of fluid therapy has been guided by FloTrac parameters as a standard clinical practice (NICE protocol)
intervention type: Device
intervention name: FloTrac
description: Stroke Volume has been maintained at 90% of the maximal Stroke Volume as in NICE protocol 2011
arm group label: case group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Valter MD Perilli, PhD
role: Principal Investigator
affiliation: Department of Anesthesiology
responsible party type: Principal Investigator
investigator affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
investigator full name: Dr.Andrea Russo
investigator title: Principal investigator
sharing ipd: Yes