<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/NCT02978430</url>
  </required_header>
  <id_info>
    <org_study_id>P2016/334</org_study_id>
    <nct_id>NCT02978430</nct_id>
  </id_info>
  <brief_title>Implementation of Computer-Assisted Intraoperative Goal-Directed Fluid Therapy</brief_title>
  <official_title>Implementation of Computer-Assisted Intraoperative Goal-Directed Fluid Therapy in Major Abdominal Surgery: A Before and After Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Erasme University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Erasme University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to compare the implementation of computer-assisted goal directed&#xD;
      fluid therapy (GDFT) to standard of care fluid therapy in major abdominal surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fluid therapy is one of the main tools used in anesthesiology to maintain adequate&#xD;
      hemodynamic stability. Goal-directed fluid therapy (GDFT) based on cardiac output and/or&#xD;
      dynamic parameters of fluid responsiveness (e.g. pulse pressure variation) has been shown to&#xD;
      decrease post-operative complications. The main inconvenience of protocol based therapy is&#xD;
      its technical complexity which requires considerable time, attention, and vigilance. GDFT&#xD;
      assisted by a closed-loop system, when compared to manual GDFT, is associated with a longer&#xD;
      preload independent state and could increase clinician adherence to protocol. To this day no&#xD;
      study has compared closed-loop assisted GDFT to standard of care.&#xD;
&#xD;
      Goal:&#xD;
&#xD;
      This study compares the results of the study entitled &quot;Crystalloids or Colloids for Goal&#xD;
      directed Fluid Therapy With Closed-loop Assistance in Major Surgery&quot; (NCT02312999) to a&#xD;
      standard of care group (started retrospectively before the first included patient of the&#xD;
      above study) where fluid therapy is based only on static variables (e.g. arterial pressure,&#xD;
      heart rate, central venous pressure (CVP), and urine output.) These groups consisted of the&#xD;
      same population undergoing the same types of surgery.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      A protocolized approach using computer-assisted GDFT when compared to standard of care is&#xD;
      associated with less fluid administration and less blood transfusions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2015</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Perioperative fluid administration</measure>
    <time_frame>24 hours</time_frame>
    <description>Fluid balance during perioperative period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of hospitalisation</measure>
    <time_frame>Every day up to 90 days after hospitalization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality rate</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transfusion of blood products during hospitalization</measure>
    <time_frame>Every day up to 90 days post surgery</time_frame>
    <description>In-hospital transfusion during hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypotension incidence during surgery</measure>
    <time_frame>24 hours</time_frame>
    <description>Incidence of hypotension (defined as total case time spent with 20% drop from baseline preoperative blood pressure)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need of vasopressor</measure>
    <time_frame>24 hours</time_frame>
    <description>Use of vasopressors during the perioperative period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal function - urea level</measure>
    <time_frame>Every day up to 90 days after hospitalization</time_frame>
    <description>Urea levels. Measured in a blood sample taken during hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal function - creatinine level</measure>
    <time_frame>Every day up to 90 days after hospitalization</time_frame>
    <description>Creatinine levels. Measured in a blood sample taken during hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative complications</measure>
    <time_frame>Every day up to 90 days after hospitalization</time_frame>
    <description>Major complications included 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 included unplanned ICU admission, pneumonia/pleural effusion, deep venous thrombosis, paralytic ileus progressive, 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">260</enrollment>
  <condition>Major Abdominal Surgery</condition>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group (started retrospectively before the first included patient of the closed-loop goal-directed fluid therapy group) consists of patients undergoing major abdominal surgery where fluid management is carried out based only on static variables (e.g. arterial pressure, heart rate, CVP, and urine output).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Computer-assisted GDFT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group consists of patients undergoing major abdominal surgery where fluid management is carried out with a closed-loop (automated) system to deliver fluid by a goal-directed fluid therapy (GDFT) standardized protocol.&#xD;
Confer: &quot;Crystalloids or Colloids for Goal-directed Fluid Therapy With Closed-loop Assistance in Major Surgery&quot; (NCT02312999)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Computer-assisted GDFT</intervention_name>
    <description>Patients receive fluid therapy via a computer-assisted goal-directed fluid therapy (GDFT) prototype closed-loop (automated) system guided by a cardiac output monitor.</description>
    <arm_group_label>Computer-assisted GDFT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of care</intervention_name>
    <description>Patients receive fluid management based only on static variables (e.g. arterial pressure, heart rate, CVP, and urine output). This control group (started retrospectively before the first included patient of the closed-loop goal directed fluid therapy group) consists of the same population undergoing the same surgery as the closed-loop GDFT group.</description>
    <arm_group_label>Standard of care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (over the age of 18) undergoing elective major abdominal surgery that&#xD;
             is expected to take longer than 3 hours and requiring general anesthesia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under 18 years of age&#xD;
&#xD;
          -  Patients not undergoing surgery, requiring anesthesia, or cardiac output monitoring&#xD;
&#xD;
          -  Patients with arrhythmia and/or atrial fibrillation&#xD;
&#xD;
          -  Patients who are allergic to HES (hydroxyethyl starch)&#xD;
&#xD;
          -  Patients with renal insufficiency (serum creatinine of &gt;2 mg/ml) or hepatic&#xD;
             dysfunction (liver enzymes &gt;1.5)&#xD;
&#xD;
          -  Patients who has coagulation disorders (values higher than 1.5x normal values)&#xD;
&#xD;
          -  Patients without the capacity to give written informed consent or refusal of consent&#xD;
&#xD;
          -  Pregnancy at time of enrollment.&#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>Scheeren TW, Wiesenack C, Gerlach H, Marx G. Goal-directed intraoperative fluid therapy guided by stroke volume and its variation in high-risk surgical patients: a prospective randomized multicentre study. J Clin Monit Comput. 2013 Jun;27(3):225-33. doi: 10.1007/s10877-013-9461-6. Epub 2013 Apr 5.</citation>
    <PMID>23558909</PMID>
  </reference>
  <reference>
    <citation>Salzwedel C, Puig J, Carstens A, Bein B, Molnar Z, Kiss K, Hussain A, Belda J, Kirov MY, Sakka SG, Reuter DA. Perioperative goal-directed hemodynamic therapy based on radial arterial pulse pressure variation and continuous cardiac index trending reduces postoperative complications after major abdominal surgery: a multi-center, prospective, randomized study. Crit Care. 2013 Sep 8;17(5):R191. doi: 10.1186/cc12885.</citation>
    <PMID>24010849</PMID>
  </reference>
  <reference>
    <citation>Spanjersberg WR, Bergs EA, Mushkudiani N, Klimek M, Schipper IB. Protocol compliance and time management in blunt trauma resuscitation. Emerg Med J. 2009 Jan;26(1):23-7. doi: 10.1136/emj.2008.058073.</citation>
    <PMID>19104091</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>November 2016</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>March 9, 2017</last_update_submitted>
  <last_update_submitted_qc>March 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fluid therapy</keyword>
  <keyword>Anesthesiology</keyword>
  <keyword>Major surgery</keyword>
  <keyword>Goal-directed fluid therapy</keyword>
  <keyword>Fluid responsiveness</keyword>
  <keyword>Closed-loop system</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02978430
org study id: P2016/334
nct id: NCT02978430
lead sponsor: 
has dmc: No
The aim of this study is to compare the implementation of computer-assisted goal directed
      fluid therapy (GDFT) to standard of care fluid therapy in major abdominal surgery.
Fluid therapy is one of the main tools used in anesthesiology to maintain adequate
      hemodynamic stability. Goal-directed fluid therapy (GDFT) based on cardiac output and/or
      dynamic parameters of fluid responsiveness (e.g. pulse pressure variation) has been shown to
      decrease post-operative complications. The main inconvenience of protocol based therapy is
      its technical complexity which requires considerable time, attention, and vigilance. GDFT
      assisted by a closed-loop system, when compared to manual GDFT, is associated with a longer
      preload independent state and could increase clinician adherence to protocol. To this day no
      study has compared closed-loop assisted GDFT to standard of care.

      Goal:

      This study compares the results of the study entitled "Crystalloids or Colloids for Goal
      directed Fluid Therapy With Closed-loop Assistance in Major Surgery" (NCT02312999) to a
      standard of care group (started retrospectively before the first included patient of the
      above study) where fluid therapy is based only on static variables (e.g. arterial pressure,
      heart rate, central venous pressure (CVP), and urine output.) These groups consisted of the
      same population undergoing the same types of surgery.

      Hypothesis:

      A protocolized approach using computer-assisted GDFT when compared to standard of care is
      associated with less fluid administration and less blood transfusions.
allocation: Non-Randomized
primary purpose: Prevention
masking: None (Open Label)
measure: Perioperative fluid administration
time frame: 24 hours
description: Fluid balance during perioperative period
measure: Length of hospitalisation
time frame: Every day up to 90 days after hospitalization
measure: Mortality rate
time frame: 30 days
measure: Transfusion of blood products during hospitalization
time frame: Every day up to 90 days post surgery
description: In-hospital transfusion during hospitalization
measure: Hypotension incidence during surgery
time frame: 24 hours
description: Incidence of hypotension (defined as total case time spent with 20% drop from baseline preoperative blood pressure)
measure: Need of vasopressor
time frame: 24 hours
description: Use of vasopressors during the perioperative period
measure: Renal function - urea level
time frame: Every day up to 90 days after hospitalization
description: Urea levels. Measured in a blood sample taken during hospitalization
measure: Renal function - creatinine level
time frame: Every day up to 90 days after hospitalization
description: Creatinine levels. Measured in a blood sample taken during hospitalization
measure: Postoperative complications
time frame: Every day up to 90 days after hospitalization
description: Major complications included 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 included unplanned ICU admission, pneumonia/pleural effusion, deep venous thrombosis, paralytic ileus progressive, renal insufficiency, infection (superficial wound infection/fever/urinary infection) and confusion/delirium.
arm group label: Standard of care
arm group type: Active Comparator
description: This group (started retrospectively before the first included patient of the closed-loop goal-directed fluid therapy group) consists of patients undergoing major abdominal surgery where fluid management is carried out based only on static variables (e.g. arterial pressure, heart rate, CVP, and urine output).
arm group label: Computer-assisted GDFT
arm group type: Active Comparator
description: This group consists of patients undergoing major abdominal surgery where fluid management is carried out with a closed-loop (automated) system to deliver fluid by a goal-directed fluid therapy (GDFT) standardized protocol.
Confer: "Crystalloids or Colloids for Goal-directed Fluid Therapy With Closed-loop Assistance in Major Surgery" (NCT02312999)
intervention type: Device
intervention name: Computer-assisted GDFT
description: Patients receive fluid therapy via a computer-assisted goal-directed fluid therapy (GDFT) prototype closed-loop (automated) system guided by a cardiac output monitor.
arm group label: Computer-assisted GDFT
intervention type: Other
intervention name: Standard of care
description: Patients receive fluid management based only on static variables (e.g. arterial pressure, heart rate, CVP, and urine output). This control group (started retrospectively before the first included patient of the closed-loop goal directed fluid therapy group) consists of the same population undergoing the same surgery as the closed-loop GDFT group.
arm group label: Standard of care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Belgium
citation: Scheeren TW, Wiesenack C, Gerlach H, Marx G. Goal-directed intraoperative fluid therapy guided by stroke volume and its variation in high-risk surgical patients: a prospective randomized multicentre study. J Clin Monit Comput. 2013 Jun;27(3):225-33. doi: 10.1007/s10877-013-9461-6. Epub 2013 Apr 5.
PMID: 23558909
citation: Salzwedel C, Puig J, Carstens A, Bein B, Molnar Z, Kiss K, Hussain A, Belda J, Kirov MY, Sakka SG, Reuter DA. Perioperative goal-directed hemodynamic therapy based on radial arterial pulse pressure variation and continuous cardiac index trending reduces postoperative complications after major abdominal surgery: a multi-center, prospective, randomized study. Crit Care. 2013 Sep 8;17(5):R191. doi: 10.1186/cc12885.
PMID: 24010849
citation: Spanjersberg WR, Bergs EA, Mushkudiani N, Klimek M, Schipper IB. Protocol compliance and time management in blunt trauma resuscitation. Emerg Med J. 2009 Jan;26(1):23-7. doi: 10.1136/emj.2008.058073.
PMID: 19104091
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
sharing ipd: Undecided