<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/NCT03779373</url>
  </required_header>
  <id_info>
    <org_study_id>2018-A03365-50</org_study_id>
    <nct_id>NCT03779373</nct_id>
  </id_info>
  <brief_title>Assisted Fluid Management in Patients Undergoing Major Abdominal and Orthopedic Surgery</brief_title>
  <acronym>AFM</acronym>
  <official_title>Manual Versus Assisted Fluid Management in Patients Undergoing Major Abdominal and Orthopedic Surgery: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Erasme University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>APHP</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Erasme University Hospital</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>
      This study will compare a group of patients managed with a manual GDFT protocol (using the&#xD;
      EV1000 monitoring device; Edwards Lifesciences, Irvine, USA) to a group of patients managed&#xD;
      using a decision support system for GDFT guidance (implemented on the same EV1000 monitoring)&#xD;
      in patients undergoing major abdominal and orthopedic surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Many trials have indicated that goal-directed fluid therapy (GDFT) strategies may benefit&#xD;
      high-risk surgical patients but these strategies are infrequently implemented. It has also&#xD;
      been shown that without any goal or protocol for fluid resuscitation, large inter- and&#xD;
      intra-provider variability exist and have been correlated with marked variations in patient&#xD;
      outcomes. Even under ideal study conditions, strict adherence to GDFT protocols is hampered&#xD;
      by the workload and concentration required for consistent implementation.Haemodynamic&#xD;
      monitors and protocols alone do not enable optimal fluid titration to be provided&#xD;
      consistently to all patients - there must also be appropriate and timely interpretation and&#xD;
      intervention.&#xD;
&#xD;
      To address this problem of consistency and protocol adherence, a clinical decision support&#xD;
      system, &quot;Assisted Fluid Management&quot; (AFM), has been designed to help ease some of the&#xD;
      workload associated with GDFT protocol implementation. The AFM system (released on the&#xD;
      European market in March 2017) may help increase GDFT protocol adherence while leaving&#xD;
      direction and guidance in the hands of the care providers. This system can suggest fluid&#xD;
      bolus administration, analyse the effects of the bolus, and continually re-assess the patient&#xD;
      for further fluid requirements.&#xD;
&#xD;
      A recent published study demonstrated that the implementation of the AFM for GDFT guidance&#xD;
      resulted in a significantly longer period during surgery with a SVV &lt;13% with a reduced total&#xD;
      amount of fluid administered without any difference in postoperative complications. Therefore&#xD;
      the goal of this randomized controlled trial is to compare a manual GDFT approach ( standard&#xD;
      of care actually in the department) versus an Assisted fluid management approach (using the&#xD;
      AFM mode) on the incidence of minor postoperative complications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Change of hospital when the study will be done. We will redo the clinical trial to have the&#xD;
    good sponsor for the study.&#xD;
  </why_stopped>
  <start_date type="Anticipated">April 1, 2019</start_date>
  <completion_date type="Anticipated">July 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Prospective randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>composite criteria of minor postoperative complications</measure>
    <time_frame>30 days postsurgery</time_frame>
    <description>This composite score includes 8 items :&#xD;
postoperative nausea and vomiting&#xD;
delirium and confusion&#xD;
Infection of surgical site&#xD;
urinary infection&#xD;
acute kidney injury (KDIGO I &amp; II classiciation)&#xD;
paralytic ileus&#xD;
other infection (skin, catheter, unknown etc)&#xD;
Readmission to the hospital within 30 days postoperative</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Time spent during the procedure with a stroke volume variation &lt; 13%</measure>
    <time_frame>Postoperative day 1</time_frame>
    <description>Percentage of Time spent during the procedure with a stroke volume variation &lt; 13%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Time spent during the procedure with a Cardiac index &gt;2.5l/min/m2</measure>
    <time_frame>Postoperative day 1</time_frame>
    <description>Percentage of Time spent during the procedure with a Cardiac index &gt;2.5l/min/m2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>composite criteria of major postoperative complications</measure>
    <time_frame>30 days postsurgery</time_frame>
    <description>This composite score includes 14 items :&#xD;
stoma dehiscence&#xD;
Peritonitis&#xD;
Sepsis&#xD;
wound dehiscence&#xD;
bleeding requiring a redo surgery&#xD;
pulmonary embolism&#xD;
pulmonary edema&#xD;
Pneumonia&#xD;
acute coronary syndrome&#xD;
atrial fibrillation&#xD;
stroke&#xD;
Dialysis&#xD;
non scheduled redo surgery&#xD;
30days mortality (all causes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cardiac index over the procedure</measure>
    <time_frame>Postoperative day 1</time_frame>
    <description>average cardiac index over the surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stroke volume over the procedure</measure>
    <time_frame>Postoperative day 1</time_frame>
    <description>average stroke volume over the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stroke volume variation over the procedure</measure>
    <time_frame>Postoperative day 1</time_frame>
    <description>average stroke volume variation over the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Fluid received during the procedure</measure>
    <time_frame>Postoperative day 1</time_frame>
    <description>amount of fluid received during surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Net fluid balance</measure>
    <time_frame>Postoperative day 1</time_frame>
    <description>Net fluid balance at the end of the ICU stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative acute care unit or intensive care unit length of stay</measure>
    <time_frame>30 days postsurgery</time_frame>
    <description>Postoperative acute care unit or intensive care unit length of stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>30 days postsurgery</time_frame>
    <description>hospital length of stay</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Goal Directed Fluid Therapy</condition>
  <arm_group>
    <arm_group_label>EV1000 monitoring</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group of patients will receive fluid administration during surgery based on a manual GDFT protocol actually in place in the department using the EV1000 monitoring device (Edwards Lifesciences, Irvine, USA)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EV1000 monioring with the decision (AFM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group of patients will receive fluid administration during surgery based on a novel clinical decision support system for GDFT guidance using the EV1000 monitoring device (Edwards Lifesciences, Irvine, USA)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Use of a decision support system on the EV1000 monitor (AFM mode)</intervention_name>
    <description>The way to administer fluid is based on the same monitoring device but will differ by the way fluid is given ( following a manual GDFT protocol versus following recommendation from an active clinical deicsion support system for fluid administration called AFM (assisted fluid management)</description>
    <arm_group_label>EV1000 monioring with the decision (AFM)</arm_group_label>
    <arm_group_label>EV1000 monitoring</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult patients in the operating room scheduled for a major abdominal &amp; orthopedic&#xD;
             surgery requiring a cardiac output monitoring (EV1000).&#xD;
&#xD;
          -  Written informed consent received before surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minor Patients.&#xD;
&#xD;
          -  No french speaking.&#xD;
&#xD;
          -  Atrial fibrillation or severe arythmia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jacques Duranteau, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Bicetre Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>APHP BICETRE</last_name>
    <role>Study Chair</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Joosten Alexandre</name>
      <address>
        <city>Paris</city>
        <state>Kremlin Bicetre</state>
        <zip>94270</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>May 10, 2019</last_update_submitted>
  <last_update_submitted_qc>May 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Erasme University Hospital</investigator_affiliation>
    <investigator_full_name>Alexandre Joosten</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT03779373
org study id: 2018-A03365-50
nct id: NCT03779373
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will compare a group of patients managed with a manual GDFT protocol (using the
      EV1000 monitoring device; Edwards Lifesciences, Irvine, USA) to a group of patients managed
      using a decision support system for GDFT guidance (implemented on the same EV1000 monitoring)
      in patients undergoing major abdominal and orthopedic surgery.
Many trials have indicated that goal-directed fluid therapy (GDFT) strategies may benefit
      high-risk surgical patients but these strategies are infrequently implemented. It has also
      been shown that without any goal or protocol for fluid resuscitation, large inter- and
      intra-provider variability exist and have been correlated with marked variations in patient
      outcomes. Even under ideal study conditions, strict adherence to GDFT protocols is hampered
      by the workload and concentration required for consistent implementation.Haemodynamic
      monitors and protocols alone do not enable optimal fluid titration to be provided
      consistently to all patients - there must also be appropriate and timely interpretation and
      intervention.

      To address this problem of consistency and protocol adherence, a clinical decision support
      system, "Assisted Fluid Management" (AFM), has been designed to help ease some of the
      workload associated with GDFT protocol implementation. The AFM system (released on the
      European market in March 2017) may help increase GDFT protocol adherence while leaving
      direction and guidance in the hands of the care providers. This system can suggest fluid
      bolus administration, analyse the effects of the bolus, and continually re-assess the patient
      for further fluid requirements.

      A recent published study demonstrated that the implementation of the AFM for GDFT guidance
      resulted in a significantly longer period during surgery with a SVV <13% with a reduced total
      amount of fluid administered without any difference in postoperative complications. Therefore
      the goal of this randomized controlled trial is to compare a manual GDFT approach ( standard
      of care actually in the department) versus an Assisted fluid management approach (using the
      AFM mode) on the incidence of minor postoperative complications.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective randomized controlled trial
primary purpose: Treatment
masking: Single (Participant)
measure: composite criteria of minor postoperative complications
time frame: 30 days postsurgery
description: This composite score includes 8 items :
postoperative nausea and vomiting
delirium and confusion
Infection of surgical site
urinary infection
acute kidney injury (KDIGO I & II classiciation)
paralytic ileus
other infection (skin, catheter, unknown etc)
Readmission to the hospital within 30 days postoperative
measure: Percentage of Time spent during the procedure with a stroke volume variation < 13%
time frame: Postoperative day 1
description: Percentage of Time spent during the procedure with a stroke volume variation < 13%
measure: Percentage of Time spent during the procedure with a Cardiac index >2.5l/min/m2
time frame: Postoperative day 1
description: Percentage of Time spent during the procedure with a Cardiac index >2.5l/min/m2
measure: composite criteria of major postoperative complications
time frame: 30 days postsurgery
description: This composite score includes 14 items :
stoma dehiscence
Peritonitis
Sepsis
wound dehiscence
bleeding requiring a redo surgery
pulmonary embolism
pulmonary edema
Pneumonia
acute coronary syndrome
atrial fibrillation
stroke
Dialysis
non scheduled redo surgery
30days mortality (all causes)
measure: cardiac index over the procedure
time frame: Postoperative day 1
description: average cardiac index over the surgery
measure: stroke volume over the procedure
time frame: Postoperative day 1
description: average stroke volume over the procedure
measure: stroke volume variation over the procedure
time frame: Postoperative day 1
description: average stroke volume variation over the procedure
measure: Total Fluid received during the procedure
time frame: Postoperative day 1
description: amount of fluid received during surgery
measure: Net fluid balance
time frame: Postoperative day 1
description: Net fluid balance at the end of the ICU stay
measure: Postoperative acute care unit or intensive care unit length of stay
time frame: 30 days postsurgery
description: Postoperative acute care unit or intensive care unit length of stay
measure: Hospital length of stay
time frame: 30 days postsurgery
description: hospital length of stay
arm group label: EV1000 monitoring
arm group type: Active Comparator
description: This group of patients will receive fluid administration during surgery based on a manual GDFT protocol actually in place in the department using the EV1000 monitoring device (Edwards Lifesciences, Irvine, USA)
arm group label: EV1000 monioring with the decision (AFM)
arm group type: Experimental
description: This group of patients will receive fluid administration during surgery based on a novel clinical decision support system for GDFT guidance using the EV1000 monitoring device (Edwards Lifesciences, Irvine, USA)
intervention type: Other
intervention name: Use of a decision support system on the EV1000 monitor (AFM mode)
description: The way to administer fluid is based on the same monitoring device but will differ by the way fluid is given ( following a manual GDFT protocol versus following recommendation from an active clinical deicsion support system for fluid administration called AFM (assisted fluid management)
arm group label: EV1000 monioring with the decision (AFM)
arm group label: EV1000 monitoring
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Jacques Duranteau, PhD
role: Study Director
affiliation: Bicetre Hospital
last name: APHP BICETRE
role: Study Chair
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Erasme University Hospital
investigator full name: Alexandre Joosten
investigator title: Principal Investigator
sharing ipd: No