<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/NCT02217969</url>
  </required_header>
  <id_info>
    <org_study_id>IRB # 24886</org_study_id>
    <nct_id>NCT02217969</nct_id>
  </id_info>
  <brief_title>Prospective Trial of Alerting to Extended Hypotensive Exposures on Long-Term Outcome After Surgery</brief_title>
  <acronym>SLUScore™</acronym>
  <official_title>Prospective, Randomized Trial of Alerting to Extended Hypotensive Exposures on Long-Term Outcome Following Adult Non-Cardiac Surgical Procedures: The SLUScore™ Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Louis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Louis University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Patients undergoing anesthesia for non-cardiac surgery will be randomized to either having&#xD;
      their anesthesia team alerted or kept blinded to extended periods of less than normal blood&#xD;
      pressure with the goal of studying if providing these alerts leads to improved outcome after&#xD;
      surgery (lower risk of death or complication in the days and weeks following surgery).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      We recently identified a significant association of postoperative morbidity and 30-day&#xD;
      mortality with the concept of &quot;hypotensive exposures&quot; during anaesthesia. Specifically, we&#xD;
      found in approximately 160,000 patients from 3 institutions (Cleveland Clinic, Vanderbilt&#xD;
      University and Saint Louis University) that roughly every third adult patient undergoing a&#xD;
      non-cardiac procedure under anaesthesia experienced twice the 30-day all-cause mortality&#xD;
      portended by extended cumulative periods of less than normal intraoperative blood pressure.&#xD;
      This association was independent of co-morbidity (Charlson Co-morbidity index), causing the&#xD;
      same relative increase in mortality in &quot;healthy&quot; as in &quot;sick&quot; patients. A new method was&#xD;
      introduced to quantify hypotensive exposures in form of a novel risk score called the&#xD;
      SLUScore™, a score with values from ranging from 0 (no hypotensive exposure) to a maximum of&#xD;
      31 (the maximal number of exposures exceeded of a certain risk-based set of limits for time&#xD;
      accumulated at a mean arterial blood pressure below thresholds between 75 and 45 mm Hg), with&#xD;
      each increment of the SLUScore™ portending an equivalent 5% increase in 30-day postoperative&#xD;
      mortality.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      We test the hypothesis that alerting the anaesthesia care team to progressive hypotensive&#xD;
      exposures (a progressive increase in their SLUScore™) improves 30-day survival. This will be&#xD;
      tested in a prospective, randomised trial.&#xD;
&#xD;
      Methods and Design:&#xD;
&#xD;
      A novel Clinical Decision Support System (ACG-Anesthesia by Talis Clinical, LLC) will be used&#xD;
      to alert anaesthesia care team members to patients' SLUScores™ in near real time (within 1&#xD;
      minute of documented exposures). At the time of transition from a SLUScore™ of 0 to 1&#xD;
      (occurring in approximately every third anaesthetic), patients will be automatically&#xD;
      randomized by the ACG-Anesthesia system to either alert or no alert (blinded) status with the&#xD;
      intent of raising awareness on the part of the anaesthesia care team in the alert group of&#xD;
      the occurrence of extended hypotensive exposures and their associated risk, allowing the team&#xD;
      to render its best clinical judgment to initiate interventions aimed at bringing patients out&#xD;
      of progressive hypotensive states. With one interim analysis planned after two years, a total&#xD;
      of 56,248 patients are projected to be enrolled over a 4-year period for this trial to be&#xD;
      powered to detect a 0.3% absolute reduction in 30-day mortality, by saving at least 50 lives&#xD;
      in the alert group after two years (two-sided p&lt;0.016) or at least 70 lives (two-sided&#xD;
      p&lt;0.019) at the conclusion of the trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    IRB application withdrawn&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 2018</start_date>
  <completion_date type="Anticipated">September 2023</completion_date>
  <primary_completion_date type="Anticipated">July 2022</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>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>30-day all-cause postoperative mortality</measure>
    <time_frame>30-days</time_frame>
    <description>This addresses the known rather high rate of death within 30 days following non-cardiac surgical or interventional procedures</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Composite outcomes</measure>
    <time_frame>one week</time_frame>
    <description>Myocardial infarction; renal failure; septic shock</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Length of Hospital Stay</measure>
    <time_frame>30 days</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Anesthesia</condition>
  <condition>Hypotension</condition>
  <arm_group>
    <arm_group_label>Electronic alert to SLUScore increase</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients whose anesthesia care team members are receiving alerts to increments in their SLUScore (progressive hypotensive exposures) are anticipated to be given interventions aimed at minimizing further hypotensive exposures. The decision of whether or not to intervene as well as the type(s) of interventions will be at the sole discretion of the patient's anesthesia care team</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control (no alert)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Routine anesthesia care at the discretion of the anesthesia care team</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Electronic alert to SLUScore increase</intervention_name>
    <description>Treat hypotension to minimize further progression of the SLUScore</description>
    <arm_group_label>Electronic alert to SLUScore increase</arm_group_label>
    <other_name>Treat hypotension</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any adult patient presenting for any type of non-cardiac procedure performed under any&#xD;
             type of anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pediatric patients (&lt; 18 yrs of age)&#xD;
&#xD;
          -  Obstetric patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wolf H. Stapelfeldt, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saint Louis University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Saint Louis University Hospital</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>March 12, 2018</last_update_submitted>
  <last_update_submitted_qc>March 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Louis University</investigator_affiliation>
    <investigator_full_name>Wolf H. Stapelfeldt, MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Anesthesia</keyword>
  <keyword>Hypotension</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypotension</mesh_term>
  </condition_browse>
  <!-- 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/NCT02217969
org study id: IRB # 24886
nct id: NCT02217969
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Patients undergoing anesthesia for non-cardiac surgery will be randomized to either having
      their anesthesia team alerted or kept blinded to extended periods of less than normal blood
      pressure with the goal of studying if providing these alerts leads to improved outcome after
      surgery (lower risk of death or complication in the days and weeks following surgery).
Background:

      We recently identified a significant association of postoperative morbidity and 30-day
      mortality with the concept of "hypotensive exposures" during anaesthesia. Specifically, we
      found in approximately 160,000 patients from 3 institutions (Cleveland Clinic, Vanderbilt
      University and Saint Louis University) that roughly every third adult patient undergoing a
      non-cardiac procedure under anaesthesia experienced twice the 30-day all-cause mortality
      portended by extended cumulative periods of less than normal intraoperative blood pressure.
      This association was independent of co-morbidity (Charlson Co-morbidity index), causing the
      same relative increase in mortality in "healthy" as in "sick" patients. A new method was
      introduced to quantify hypotensive exposures in form of a novel risk score called the
      SLUScore™, a score with values from ranging from 0 (no hypotensive exposure) to a maximum of
      31 (the maximal number of exposures exceeded of a certain risk-based set of limits for time
      accumulated at a mean arterial blood pressure below thresholds between 75 and 45 mm Hg), with
      each increment of the SLUScore™ portending an equivalent 5% increase in 30-day postoperative
      mortality.

      Hypothesis:

      We test the hypothesis that alerting the anaesthesia care team to progressive hypotensive
      exposures (a progressive increase in their SLUScore™) improves 30-day survival. This will be
      tested in a prospective, randomised trial.

      Methods and Design:

      A novel Clinical Decision Support System (ACG-Anesthesia by Talis Clinical, LLC) will be used
      to alert anaesthesia care team members to patients' SLUScores™ in near real time (within 1
      minute of documented exposures). At the time of transition from a SLUScore™ of 0 to 1
      (occurring in approximately every third anaesthetic), patients will be automatically
      randomized by the ACG-Anesthesia system to either alert or no alert (blinded) status with the
      intent of raising awareness on the part of the anaesthesia care team in the alert group of
      the occurrence of extended hypotensive exposures and their associated risk, allowing the team
      to render its best clinical judgment to initiate interventions aimed at bringing patients out
      of progressive hypotensive states. With one interim analysis planned after two years, a total
      of 56,248 patients are projected to be enrolled over a 4-year period for this trial to be
      powered to detect a 0.3% absolute reduction in 30-day mortality, by saving at least 50 lives
      in the alert group after two years (two-sided p<0.016) or at least 70 lives (two-sided
      p<0.019) at the conclusion of the trial.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: Double (Participant, Care Provider)
measure: 30-day all-cause postoperative mortality
time frame: 30-days
description: This addresses the known rather high rate of death within 30 days following non-cardiac surgical or interventional procedures
measure: Composite outcomes
time frame: one week
description: Myocardial infarction; renal failure; septic shock
measure: Length of Hospital Stay
time frame: 30 days
arm group label: Electronic alert to SLUScore increase
arm group type: Experimental
description: Patients whose anesthesia care team members are receiving alerts to increments in their SLUScore (progressive hypotensive exposures) are anticipated to be given interventions aimed at minimizing further hypotensive exposures. The decision of whether or not to intervene as well as the type(s) of interventions will be at the sole discretion of the patient's anesthesia care team
arm group label: Control (no alert)
arm group type: No Intervention
description: Routine anesthesia care at the discretion of the anesthesia care team
intervention type: Behavioral
intervention name: Electronic alert to SLUScore increase
description: Treat hypotension to minimize further progression of the SLUScore
arm group label: Electronic alert to SLUScore increase
other name: Treat hypotension
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Wolf H. Stapelfeldt, M.D.
role: Principal Investigator
affiliation: Saint Louis University School of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: St. Louis University
investigator full name: Wolf H. Stapelfeldt, MD
investigator title: Professor
mesh term: Hypotension