xml: <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/NCT06011187</url>
    </required_header>
    <id_info>
      <org_study_id>APHP 220817</org_study_id>
      <nct_id>NCT06011187</nct_id>
    </id_info>
    <brief_title>Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery</brief_title>
    <acronym>PEFLA</acronym>
    <official_title>&quot;Personalized Fluid Administration Using an AFM System for Goal Directed Fluid Therapy on Postoperative Outcome in High-risk Patients Undergoing High-risk Abdominal Surgery: A Multicenter Stepped-wedge, Cluster-randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assistance Publique - Hôpitaux de Paris</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assistance Publique - Hôpitaux de Paris</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Goal directed fluid therapy (GDFT) or &quot;Personalized fluid therapy&quot; may benefit high-risk&#xD;
        surgical patients but these strategies are infrequently implemented. It has also been shown&#xD;
        that without any goal or protocol for fluid resuscitation, large inter- and intra-provider&#xD;
        variability exist that have been correlated with poor patient outcomes.&#xD;
  &#xD;
        Recently, an &quot;Assisted Fluid Management&quot; (AFM) system has been developed to help ease some of&#xD;
        the work associated with GDFT protocol implementation. The AFM system may help increase GDFT&#xD;
        protocol adherence while leaving direction and guidance in the hands of the care providers.&#xD;
        This artificial intelligence-based system can suggest administration of fluid boluses,&#xD;
        analyse the hemodynamic effects of the bolus, and continually re-assess the patient for&#xD;
        further fluid requirements.&#xD;
  &#xD;
        To date, there are no large outcome study using this AFM system. The primary objective of&#xD;
        this trial is thus to evaluate the impact of this AFM system to guide fluid bolus&#xD;
        administration on a composite of major postoperative complications in high-risk patients&#xD;
        undergoing high-risk abdominal surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Many trials have indicated that goal-directed fluid therapy (GDFT) strategies or more&#xD;
        recently &quot;personalized fluid therapy&quot; may benefit high-risk surgical patients but these&#xD;
        strategies are infrequently implemented. It has also been shown that without any goal or&#xD;
        protocol for fluid resuscitation, large inter- and intra-provider variability exist that have&#xD;
        been correlated with poor patient outcomes. Even under ideal study conditions, strict&#xD;
        adherence to GDFT protocols is hampered by the workload and concentration required for&#xD;
        consistent implementation. Hemodynamic monitors and protocols alone do not enable optimal&#xD;
        fluid titration to be provided consistently to all patients - there must also be appropriate&#xD;
        and timely interpretation and intervention.&#xD;
  &#xD;
        To address this problem of consistency and protocol adherence, a decision support system,&#xD;
        &quot;Assisted Fluid Management&quot; (AFM), has been developed to help ease some of the work&#xD;
        associated with GDFT protocol implementation. The AFM system (released on the European market&#xD;
        in March 2017) may help increase GDFT protocol adherence while leaving direction and guidance&#xD;
        in the hands of the care providers. This artificial intelligence-based system can suggest&#xD;
        administration of fluid boluses, analyse the hemodynamic effects of the bolus, and&#xD;
        continually re-assess the patient for further fluid requirements.&#xD;
  &#xD;
        This system was recently implemented in a before-and-after study in a Belgian academic&#xD;
        hospital, where the authors reported that the implementation of this AFM software system&#xD;
        allowed a better adherence to the GDFT algorithm. However, as this was a pilot study with a&#xD;
        small number of patients, the study was not powered to demonstrate a beneficial effect on the&#xD;
        incidence of postoperative complications. More recently, a group from the Cleveland Clinic&#xD;
        demonstrated that using AFM system resulted in more boluses being effective when compared to&#xD;
        the administration of boluses without AFM support.&#xD;
  &#xD;
        There are no randomized controlled studies to date comparing this AFM system to standard of&#xD;
        care on patient outcome. We therefore aim to conduct a multicenter stepped-wedge,&#xD;
        cluster-randomized trial involving patients undergoing high risk abdominal surgery to compare&#xD;
        a GDFT strategy guided by the AFM system with usual care.&#xD;
  &#xD;
        A stepped wedge, cluster-randomized trial approach was chosen in which clusters will be&#xD;
        randomized to commence the intervention at different times following an initial control&#xD;
        period in which outcomes will be measured for usual care.&#xD;
  &#xD;
        So, each center (cluster) began in the control phase and transitioned to the intervention&#xD;
        phase at a randomly assigned time (wedge). The order in which each center will move from&#xD;
        control to intervention phase will be randomly allocated by a computer algorithm performed by&#xD;
        the study statistician.&#xD;
  &#xD;
        We selected cluster randomization rather than randomization of individual patients because&#xD;
        the control group could be very different among centers (from GDFT strategy using a flow&#xD;
        monitoring to GDFT with a written protocol to no clear strategy (use of an arterial line only&#xD;
        without any advanced monitoring). Interestingly, this approach also decreases the Hawthorne&#xD;
        effect which has been shown to decrease the incidence rate of the primary outcome in recent&#xD;
        randomized trials because clinicians know that their patients are included in a research&#xD;
        protocol.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 19, 2023</start_date>
    <completion_date type="Anticipated">December 19, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 19, 2025</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>Stepped wedge cluster randomized controlled trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>Outcome assessor will be blinded and a data monitoring willbe done on data</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Composite endpoint (&quot;any event versus none&quot;) of major postoperative complications within 30 days after surgery</measure>
      <time_frame>Postoperative day 30</time_frame>
      <description>It includes : acute myocardial injury, including myocardial infarction, acute kidney injury, severe infectious complications (including deep surgical site infection, pneumonia, sepsis, peritonitis), anastomotic leakage, pulmonary embolism or venous thrombosis, pulmonary edema, acute respiratory distress syndrome, de novo arrhythmia, stroke, reoperation for any cause, non-fatal cardiac arrest, and mortality within 30 days after surgery</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence of each of the individual components of the composite primary outcome within 30 days after surgery</measure>
      <time_frame>Postoperative day 30</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of the composite primary outcome within 7 days after surgery</measure>
      <time_frame>Postoperative day 7</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of a composite of postoperative infection rate within 30-day of surgery.</measure>
      <time_frame>Postoperative day 30</time_frame>
      <description>This is defined as one or more of the following infections: surgical site infection, organ space surgical-site infection, urinary tract infection, laboratory-confirmed blood stream infection or infection, source uncertain (this is defined as an infection which could be more than one of the above but it is unclear which)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clavien-dindo classification score</measure>
      <time_frame>Postoperative day 30</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Comprehensive complication index (CCI)</measure>
      <time_frame>Postoperative day 30</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of stay in the hospital</measure>
      <time_frame>Postoperative day 30</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of unplanned hospital re-admission within 30 days after surgery</measure>
      <time_frame>Postoperative day 30</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mortality rate at 90 days after surgery.</measure>
      <time_frame>Postoperative day 90</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">2000</enrollment>
    <condition>Decision Support System</condition>
    <condition>Outcome</condition>
    <arm_group>
      <arm_group_label>Routine care</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>During the pre-implementation period, fluid therapy will be done as routine care.&#xD;
  Mean arterial pressure (MAP) will be maintained between 65-70 mmHg per standard of care</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Assisted fluid management system</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In the post-implementation period, fluid bolus administration will be guided by the AFM recommandation.&#xD;
  MAP will be maintained between 65-70 mmHg per standard of care</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Routine care</intervention_name>
      <description>Fluid administration will be given per routine care MAP between 65 - 70 mmHg</description>
      <arm_group_label>Routine care</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>AFM</intervention_name>
      <description>AFM will recommand fluid bolus administration and MAP will be maintained between 65 and 70 mmHg</description>
      <arm_group_label>Assisted fluid management system</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Any adult patient (aged 18 years or older) admitted to the operating room for an&#xD;
               elective high-risk abdominal surgery (both open and laparoscopically assisted).&#xD;
  &#xD;
            -  Patients must fulfill at least one of the following high-risk criteria:&#xD;
  &#xD;
            -  American Society of Anesthesiologists physical status &gt; 2&#xD;
  &#xD;
            -  classification exercise tolerance &lt; 4 metabolic equivalents as defined by the&#xD;
               guidelines of the American College of Cardiology/ American Heart Association&#xD;
  &#xD;
            -  renal impairment (serum creatinine ≥1.3mg/dL or &gt;115 mmol/l or estimated glomerular&#xD;
               filtration rate &lt; 90 mL/min/1.73 m2 within the last 6 months) or renal replacement&#xD;
               therapy&#xD;
  &#xD;
            -  coronary artery disease (any stage)&#xD;
  &#xD;
            -  chronic heart failure (New York Heart Association Functional Classifcation ≥ II)&#xD;
  &#xD;
            -  valvular heart disease (moderate or severe);&#xD;
  &#xD;
            -  history of stroke&#xD;
  &#xD;
            -  peripheral arterial occlusive disease (any stage)&#xD;
  &#xD;
            -  chronic obstructive pulmonary disease (any stage) or pulmonary fibrosis (any stage)&#xD;
  &#xD;
            -  diabetes mellitus requiring oral hypoglycemic agent or insulin; immunodeficiency due&#xD;
               to a disease (e.g., HIV, leukemia, multiple myeloma, solid organ cancer) or therapy&#xD;
               (e.g., immunosuppressants, chemotherapy, radiation, steroids)&#xD;
  &#xD;
            -  liver cirrhosis (any Child-Pugh class)&#xD;
  &#xD;
               -- body mass index ≥30 kg/m2&#xD;
  &#xD;
            -  current smoking or 15 pack-year history of smoking&#xD;
  &#xD;
            -  All participants must receive clear study information and give signed informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with preoperative cardiac arrhythmias (atrial fibrillation) as the monitoring&#xD;
               devices are not accurate under cardiac arrhythmias.&#xD;
  &#xD;
            -  No affiliation with the French health care system&#xD;
  &#xD;
            -  Patients participating in another randomized controlled trial with the same clinical&#xD;
               endpoint, or interventions possibly compromising the primary outcome.&#xD;
  &#xD;
            -  Pregnant patients&#xD;
  &#xD;
            -  Patient on AME (state medical aid) (unless exemption from affiliation)&#xD;
  &#xD;
            -  Patients guardianship/legal protection/curatorship&#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>ALEXANDRE JOOSTEN, MD PhD</last_name>
      <role>Study Director</role>
      <affiliation>PAUL BROUSSE HOSPITAL</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>ALEXANDRE JOOSTEN, MD PhD</last_name>
      <phone>+33145213441</phone>
      <email>joosten-alexandre@hotmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jacques DURANTEAU, MD PhD</last_name>
      <phone>+33145213441</phone>
      <email>jacques.duranteau@aphp.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of California IRVINE</name>
        <address>
          <city>Irvine</city>
          <state>California</state>
          <zip>92868</zip>
          <country>United States</country>
        </address>
      </facility>
      <investigator>
        <last_name>Joseph Rinehart, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Sean Coeckelenbergh, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of California Los Angeles (UCLA)</name>
        <address>
          <city>Los Angeles</city>
          <state>California</state>
          <zip>90095</zip>
          <country>United States</country>
        </address>
      </facility>
      <investigator>
        <last_name>David BOLDT, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Alexandre JOOSTEN, MD PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>UZ Brussels</name>
        <address>
          <city>Brussel</city>
          <country>Belgium</country>
        </address>
      </facility>
      <investigator>
        <last_name>Domien VANHONACKER, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>CHUM Montreal</name>
        <address>
          <city>Montréal</city>
          <state>Montreal</state>
          <country>Canada</country>
        </address>
      </facility>
      <investigator>
        <last_name>Francois-martin Carrier, MD PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Maxime Soucy-Proulx, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Centre chirurgical Marie Lannelongue</name>
        <address>
          <city>Le Plessis-Robinson</city>
          <state>Haut De Seine</state>
          <country>France</country>
        </address>
      </facility>
      <investigator>
        <last_name>Amelie DELAPORTE, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Maria-christina KASSAB, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>BICETRE</name>
        <address>
          <city>Le Kremlin-Bicêtre</city>
          <state>Paris</state>
          <country>France</country>
        </address>
      </facility>
      <investigator>
        <last_name>Alexandre JOOSTEN, MD PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>CHU Clermont-Ferrand</name>
        <address>
          <city>Clermont-Ferrand</city>
          <country>France</country>
        </address>
      </facility>
      <investigator>
        <last_name>Emmanuel Futier, MD PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Chu Dijon</name>
        <address>
          <city>Dijon</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Pierre grefoire GUINOT, MD PhD</last_name>
      </contact>
      <investigator>
        <last_name>Pierre Gregoire GUINOT, MD PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Chu Lille</name>
        <address>
          <city>Lille</city>
          <country>France</country>
        </address>
      </facility>
      <investigator>
        <last_name>Gilles LEBUFFE, MD PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Centre hospitalier universitaire de NANCY</name>
        <address>
          <city>Nancy</city>
          <country>France</country>
        </address>
      </facility>
      <investigator>
        <last_name>Philippe GUERCI, MD PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>BEAUJON</name>
        <address>
          <city>Paris</city>
          <country>France</country>
        </address>
      </facility>
      <investigator>
        <last_name>Emmanuel WEISS, MD PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>HEGP</name>
        <address>
          <city>Paris</city>
          <country>France</country>
        </address>
      </facility>
      <investigator>
        <last_name>Bernard CHOLLEY, MD PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Insititut Mutualiste Montsouris</name>
        <address>
          <city>Paris</city>
          <country>France</country>
        </address>
      </facility>
      <investigator>
        <last_name>Marc BEAUSSIER, MD PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>La Pitie Salpetriere</name>
        <address>
          <city>Paris</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Alexandre SITBON, MD</last_name>
      </contact>
      <investigator>
        <last_name>Alexandre JOOSTEN, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Chu Toulouse</name>
        <address>
          <city>Toulouse</city>
          <country>France</country>
        </address>
      </facility>
      <investigator>
        <last_name>Vincent MINCVILLE, MD PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University Medical Center Hamburg-Eppendorf</name>
        <address>
          <city>Hamburg</city>
          <country>Germany</country>
        </address>
      </facility>
      <investigator>
        <last_name>Moritz FLICK, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Benrd SAUGEL, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Belgium</country>
      <country>Canada</country>
      <country>France</country>
      <country>Germany</country>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>hemodynamic</keyword>
    <keyword>fluid administration</keyword>
    <keyword>postoperative complications</keyword>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06011187
  org study id: APHP 220817
  nct id: NCT06011187
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  Goal directed fluid therapy (GDFT) or "Personalized fluid therapy" 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 that have been correlated with poor patient outcomes.
  
        Recently, an "Assisted Fluid Management" (AFM) system has been developed to help ease some of
        the work associated with GDFT protocol implementation. The AFM system may help increase GDFT
        protocol adherence while leaving direction and guidance in the hands of the care providers.
        This artificial intelligence-based system can suggest administration of fluid boluses,
        analyse the hemodynamic effects of the bolus, and continually re-assess the patient for
        further fluid requirements.
  
        To date, there are no large outcome study using this AFM system. The primary objective of
        this trial is thus to evaluate the impact of this AFM system to guide fluid bolus
        administration on a composite of major postoperative complications in high-risk patients
        undergoing high-risk abdominal surgery.
  Many trials have indicated that goal-directed fluid therapy (GDFT) strategies or more
        recently "personalized fluid therapy" 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 that have
        been correlated with poor patient outcomes. Even under ideal study conditions, strict
        adherence to GDFT protocols is hampered by the workload and concentration required for
        consistent implementation. Hemodynamic 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 decision support system,
        "Assisted Fluid Management" (AFM), has been developed to help ease some of the work
        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 artificial intelligence-based system can suggest
        administration of fluid boluses, analyse the hemodynamic effects of the bolus, and
        continually re-assess the patient for further fluid requirements.
  
        This system was recently implemented in a before-and-after study in a Belgian academic
        hospital, where the authors reported that the implementation of this AFM software system
        allowed a better adherence to the GDFT algorithm. However, as this was a pilot study with a
        small number of patients, the study was not powered to demonstrate a beneficial effect on the
        incidence of postoperative complications. More recently, a group from the Cleveland Clinic
        demonstrated that using AFM system resulted in more boluses being effective when compared to
        the administration of boluses without AFM support.
  
        There are no randomized controlled studies to date comparing this AFM system to standard of
        care on patient outcome. We therefore aim to conduct a multicenter stepped-wedge,
        cluster-randomized trial involving patients undergoing high risk abdominal surgery to compare
        a GDFT strategy guided by the AFM system with usual care.
  
        A stepped wedge, cluster-randomized trial approach was chosen in which clusters will be
        randomized to commence the intervention at different times following an initial control
        period in which outcomes will be measured for usual care.
  
        So, each center (cluster) began in the control phase and transitioned to the intervention
        phase at a randomly assigned time (wedge). The order in which each center will move from
        control to intervention phase will be randomly allocated by a computer algorithm performed by
        the study statistician.
  
        We selected cluster randomization rather than randomization of individual patients because
        the control group could be very different among centers (from GDFT strategy using a flow
        monitoring to GDFT with a written protocol to no clear strategy (use of an arterial line only
        without any advanced monitoring). Interestingly, this approach also decreases the Hawthorne
        effect which has been shown to decrease the incidence rate of the primary outcome in recent
        randomized trials because clinicians know that their patients are included in a research
        protocol.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Stepped wedge cluster randomized controlled trial
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: Outcome assessor will be blinded and a data monitoring willbe done on data
  measure: Composite endpoint ("any event versus none") of major postoperative complications within 30 days after surgery
  time frame: Postoperative day 30
  description: It includes : acute myocardial injury, including myocardial infarction, acute kidney injury, severe infectious complications (including deep surgical site infection, pneumonia, sepsis, peritonitis), anastomotic leakage, pulmonary embolism or venous thrombosis, pulmonary edema, acute respiratory distress syndrome, de novo arrhythmia, stroke, reoperation for any cause, non-fatal cardiac arrest, and mortality within 30 days after surgery
  measure: Incidence of each of the individual components of the composite primary outcome within 30 days after surgery
  time frame: Postoperative day 30
  measure: Incidence of the composite primary outcome within 7 days after surgery
  time frame: Postoperative day 7
  measure: Incidence of a composite of postoperative infection rate within 30-day of surgery.
  time frame: Postoperative day 30
  description: This is defined as one or more of the following infections: surgical site infection, organ space surgical-site infection, urinary tract infection, laboratory-confirmed blood stream infection or infection, source uncertain (this is defined as an infection which could be more than one of the above but it is unclear which)
  measure: Clavien-dindo classification score
  time frame: Postoperative day 30
  measure: Comprehensive complication index (CCI)
  time frame: Postoperative day 30
  measure: Length of stay in the hospital
  time frame: Postoperative day 30
  measure: Incidence of unplanned hospital re-admission within 30 days after surgery
  time frame: Postoperative day 30
  measure: Mortality rate at 90 days after surgery.
  time frame: Postoperative day 90
  arm group label: Routine care
  arm group type: Active Comparator
  description: During the pre-implementation period, fluid therapy will be done as routine care.
  Mean arterial pressure (MAP) will be maintained between 65-70 mmHg per standard of care
  arm group label: Assisted fluid management system
  arm group type: Experimental
  description: In the post-implementation period, fluid bolus administration will be guided by the AFM recommandation.
  MAP will be maintained between 65-70 mmHg per standard of care
  intervention type: Procedure
  intervention name: Routine care
  description: Fluid administration will be given per routine care MAP between 65 - 70 mmHg
  arm group label: Routine care
  intervention type: Device
  intervention name: AFM
  description: AFM will recommand fluid bolus administration and MAP will be maintained between 65 and 70 mmHg
  arm group label: Assisted fluid management system
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: ALEXANDRE JOOSTEN, MD PhD
  role: Study Director
  affiliation: PAUL BROUSSE HOSPITAL
  last name: ALEXANDRE JOOSTEN, MD PhD
  phone: +33145213441
  email: joosten-alexandre@hotmail.com
  last name: Jacques DURANTEAU, MD PhD
  phone: +33145213441
  email: jacques.duranteau@aphp.fr
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  country: Belgium
  country: Canada
  country: France
  country: Germany
  country: United States
  responsible party type: Sponsor
  sharing ipd: Undecided