<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/NCT03039946</url>
  </required_header>
  <id_info>
    <org_study_id>P2016/526</org_study_id>
    <nct_id>NCT03039946</nct_id>
  </id_info>
  <brief_title>Automated Closed-Loop Versus Restrictive Fluid Therapy in Abdominal Surgery</brief_title>
  <official_title>Automated Closed-Loop Versus Restrictive Fluid Therapy in Abdominal Surgery: a Pilot Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Erasme University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Erasme University Hospital</source>
  <brief_summary>
    <textblock>
      The aim of this study is to compare hemodynamic variables and outcome in patients undergoing&#xD;
      laparoscopic and/or robotic elective abdominal surgery. Patients will receive either an&#xD;
      automated closed-loop goal-directed fluid therapy (GDFT) guided by non-invasive flow&#xD;
      monitoring or a restrictive fluid therapy of 4ml/kg/h.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Perioperative fluid management is a topic of much debate that has intensified over recent&#xD;
      years. Studies have shown improved postoperative outcomes with restricted fluid&#xD;
      administration in the perioperative period for moderate risk abdominal surgery. They&#xD;
      concluded that in patients undergoing elective abdominal surgery, intraoperative restrictive&#xD;
      fluid management was associated with a reduction in postoperative morbidity and shortened&#xD;
      hospital stay. Current standard practice is a crystalloid based fluid therapy guided by&#xD;
      static hemodynamic parameters such as heart rate, blood pressure, and diuresis. However,&#xD;
      several studies have criticized this cookbook approach and recommend tailoring management to&#xD;
      specific physiologic dynamic endpoints such as stroke volume variation and cardiac output&#xD;
      using a flow monitoring device. Our team has demonstrated that the use of a closed-loop&#xD;
      system is feasible and allows precise titration of fluid administration in abdominal and&#xD;
      vascular surgery using either a minimally or a non-invasive monitoring system.&#xD;
&#xD;
      Goal:&#xD;
&#xD;
      This study compares hemodynamic variables and outcome in patients who will receive either&#xD;
      automated closed-loop fluid therapy guided by non-invasive flow monitoring or restrictive&#xD;
      fluid therapy of 4ml/kg/h. Both groups consist of the same population undergoing laparoscopic&#xD;
      and/or robotic surgery.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      A closed-loop assisted intraoperative GDFT when compared to restrictive fluid therapy will&#xD;
      provide better hemodynamic variables.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Preload independent state</measure>
    <time_frame>6 hours</time_frame>
    <description>The percentage intraoperative time spent with stroke volume variation &lt; 13% and/or cardiac index &gt; 2.4 L/min/m2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Additional fluids administered intraoperatively</measure>
    <time_frame>6 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of closed-loop override by the attending anesthesiologist</measure>
    <time_frame>6 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>up to 90 days post surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative complications</measure>
    <time_frame>up to 90 days after hospitalization</time_frame>
    <description>Major complications include cardiac (acute coronary syndrome/ arrhythmia), pulmonary (embolism/edema), gastrointestinal (bowel and surgical anastomotic leak/internal or external fistulas/peritoneal effusions), renal (renal failure requiring dialysis), infectious (peritonitis/ sepsis), coagulation (bleeding), wound dehiscence, stroke, reoperation, readmission, and death.&#xD;
Minor complications include unplanned ICU admission, pneumonia/pleural effusion, deep venous thrombosis, paralytic ileus, renal insufficiency, infection (superficial wound infection/fever/urinary infection) and confusion/delirium.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Abdominal Laparoscopic and/or Robotic Surgery</condition>
  <arm_group>
    <arm_group_label>Closed-loop GDFT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group consists of patients undergoing laparoscopic and/or robotic abdominal surgery where fluid maintenance with Plasmalyte is carried out using a closed-loop system guided by the Clearsight non-invasive hemodynamic flow monitor.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Restrictive fluid therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group consists of patients undergoing laparoscopic and/or robotic abdominal surgery where fluid management is based on a restrictive (4ml/kg/h) Plasmalyte infusion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Closed-Loop GDFT</intervention_name>
    <description>Patients receive fluids in the form of 100ml boluses of crystalloid (Plasmalyte) over 6 minutes via an automated closed-loop goal-directed fluid therapy (GDFT) system guided by non-invasive flow monitoring (Clearsight system). Additional boluses of colloid or crystalloid can be administered under the attending anesthesiologist's discretion (e.g. to compensate blood loss) .</description>
    <arm_group_label>Closed-loop GDFT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Restrictive Fluid Therapy</intervention_name>
    <description>Patients receive fluids (Plasmalyte) via a restrictive approach with a baseline of of 4ml/kg/h. Additional boluses of colloid or crystalloid can be administered under the attending anesthesiologist's discretion (e.g. to compensate blood loss) .</description>
    <arm_group_label>Restrictive fluid therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Laparoscopic and/or robotic elective abdominal surgery( colorectal, gynecological,&#xD;
             urological)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intraoperative invasive monitoring (arterial line)&#xD;
&#xD;
          -  Open colorectal surgery (laparotomy)&#xD;
&#xD;
          -  Emergency surgery&#xD;
&#xD;
          -  Expected intraoperative blood loss greater than 1000ml&#xD;
&#xD;
          -  Arrhythmia (e.g. atrial fibrillation)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Erasme University Hospital</name>
      <address>
        <city>Brussels</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <reference>
    <citation>Donati A, Loggi S, Preiser JC, Orsetti G, Munch C, Gabbanelli V, Pelaia P, Pietropaoli P. Goal-directed intraoperative therapy reduces morbidity and length of hospital stay in high-risk surgical patients. Chest. 2007 Dec;132(6):1817-24. doi: 10.1378/chest.07-0621. Epub 2007 Oct 9.</citation>
    <PMID>17925428</PMID>
  </reference>
  <reference>
    <citation>Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Nov;103(5):637-46. doi: 10.1093/bja/aep279.</citation>
    <PMID>19837807</PMID>
  </reference>
  <reference>
    <citation>Rinehart J, Lilot M, Lee C, Joosten A, Huynh T, Canales C, Imagawa D, Demirjian A, Cannesson M. Closed-loop assisted versus manual goal-directed fluid therapy during high-risk abdominal surgery: a case-control study with propensity matching. Crit Care. 2015 Mar 19;19(1):94. doi: 10.1186/s13054-015-0827-7.</citation>
    <PMID>25888403</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>March 27, 2017</last_update_submitted>
  <last_update_submitted_qc>March 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fluid therapy</keyword>
  <keyword>Hemodynamic flow monitoring</keyword>
  <keyword>Closed-loop system</keyword>
  <keyword>Goal-directed fluid therapy</keyword>
  <keyword>Anesthesiology</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/NCT03039946
org study id: P2016/526
nct id: NCT03039946
lead sponsor: 
The aim of this study is to compare hemodynamic variables and outcome in patients undergoing
      laparoscopic and/or robotic elective abdominal surgery. Patients will receive either an
      automated closed-loop goal-directed fluid therapy (GDFT) guided by non-invasive flow
      monitoring or a restrictive fluid therapy of 4ml/kg/h.
Perioperative fluid management is a topic of much debate that has intensified over recent
      years. Studies have shown improved postoperative outcomes with restricted fluid
      administration in the perioperative period for moderate risk abdominal surgery. They
      concluded that in patients undergoing elective abdominal surgery, intraoperative restrictive
      fluid management was associated with a reduction in postoperative morbidity and shortened
      hospital stay. Current standard practice is a crystalloid based fluid therapy guided by
      static hemodynamic parameters such as heart rate, blood pressure, and diuresis. However,
      several studies have criticized this cookbook approach and recommend tailoring management to
      specific physiologic dynamic endpoints such as stroke volume variation and cardiac output
      using a flow monitoring device. Our team has demonstrated that the use of a closed-loop
      system is feasible and allows precise titration of fluid administration in abdominal and
      vascular surgery using either a minimally or a non-invasive monitoring system.

      Goal:

      This study compares hemodynamic variables and outcome in patients who will receive either
      automated closed-loop fluid therapy guided by non-invasive flow monitoring or restrictive
      fluid therapy of 4ml/kg/h. Both groups consist of the same population undergoing laparoscopic
      and/or robotic surgery.

      Hypothesis:

      A closed-loop assisted intraoperative GDFT when compared to restrictive fluid therapy will
      provide better hemodynamic variables.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Preload independent state
time frame: 6 hours
description: The percentage intraoperative time spent with stroke volume variation < 13% and/or cardiac index > 2.4 L/min/m2
measure: Additional fluids administered intraoperatively
time frame: 6 hours
measure: Number of closed-loop override by the attending anesthesiologist
time frame: 6 hours
measure: Hospital length of stay
time frame: up to 90 days post surgery
measure: Postoperative complications
time frame: up to 90 days after hospitalization
description: Major complications include cardiac (acute coronary syndrome/ arrhythmia), pulmonary (embolism/edema), gastrointestinal (bowel and surgical anastomotic leak/internal or external fistulas/peritoneal effusions), renal (renal failure requiring dialysis), infectious (peritonitis/ sepsis), coagulation (bleeding), wound dehiscence, stroke, reoperation, readmission, and death.
Minor complications include unplanned ICU admission, pneumonia/pleural effusion, deep venous thrombosis, paralytic ileus, renal insufficiency, infection (superficial wound infection/fever/urinary infection) and confusion/delirium.
arm group label: Closed-loop GDFT
arm group type: Experimental
description: This group consists of patients undergoing laparoscopic and/or robotic abdominal surgery where fluid maintenance with Plasmalyte is carried out using a closed-loop system guided by the Clearsight non-invasive hemodynamic flow monitor.
arm group label: Restrictive fluid therapy
arm group type: Active Comparator
description: This group consists of patients undergoing laparoscopic and/or robotic abdominal surgery where fluid management is based on a restrictive (4ml/kg/h) Plasmalyte infusion.
intervention type: Device
intervention name: Closed-Loop GDFT
description: Patients receive fluids in the form of 100ml boluses of crystalloid (Plasmalyte) over 6 minutes via an automated closed-loop goal-directed fluid therapy (GDFT) system guided by non-invasive flow monitoring (Clearsight system). Additional boluses of colloid or crystalloid can be administered under the attending anesthesiologist's discretion (e.g. to compensate blood loss) .
arm group label: Closed-loop GDFT
intervention type: Other
intervention name: Restrictive Fluid Therapy
description: Patients receive fluids (Plasmalyte) via a restrictive approach with a baseline of of 4ml/kg/h. Additional boluses of colloid or crystalloid can be administered under the attending anesthesiologist's discretion (e.g. to compensate blood loss) .
arm group label: Restrictive fluid therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Belgium
citation: Donati A, Loggi S, Preiser JC, Orsetti G, Munch C, Gabbanelli V, Pelaia P, Pietropaoli P. Goal-directed intraoperative therapy reduces morbidity and length of hospital stay in high-risk surgical patients. Chest. 2007 Dec;132(6):1817-24. doi: 10.1378/chest.07-0621. Epub 2007 Oct 9.
PMID: 17925428
citation: Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Nov;103(5):637-46. doi: 10.1093/bja/aep279.
PMID: 19837807
citation: Rinehart J, Lilot M, Lee C, Joosten A, Huynh T, Canales C, Imagawa D, Demirjian A, Cannesson M. Closed-loop assisted versus manual goal-directed fluid therapy during high-risk abdominal surgery: a case-control study with propensity matching. Crit Care. 2015 Mar 19;19(1):94. doi: 10.1186/s13054-015-0827-7.
PMID: 25888403
responsible party type: Sponsor