<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/NCT04430920</url>
  </required_header>
  <id_info>
    <org_study_id>NFEC-2019-261</org_study_id>
    <nct_id>NCT04430920</nct_id>
  </id_info>
  <brief_title>Blood Pressure Management on Cardiovascular AdveRse Events After Major Abdominal Surgery</brief_title>
  <acronym>BP-CARES</acronym>
  <official_title>Blood Pressure Management on Cardiovascular AdveRse Events After Major Abdominal Surgery (BP-CARES): A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanfang Hospital, Southern Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Xinqiao Hospital of Chongqing</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Henan Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nanfang Hospital, Southern Medical 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>
      This study is a multicenter randomized controlled trial comparing an intensive intraoperative&#xD;
      blood pressure management strategy versus conventional practice for preventing cardiovascular&#xD;
      events in high-risk patients undergoing major abdominal surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intraoperative hypotension has been associated with cardiovascular events after non-cardiac&#xD;
      surgery. However, whether avoiding intraoperative hypotension can reduce the incidence of&#xD;
      postoperative cardiovascular events remains unclear. The objective of this study is to assess&#xD;
      the effects of an intensive intraoperative blood pressure management strategy (to maintain&#xD;
      intraoperative MAP ≥ 80mmHg) with that of conventional practice (to maintain intraoperative&#xD;
      MAP ≥ 65mmHg) on the incidence of cardiovascular events after major abdominal surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 30, 2020</start_date>
  <completion_date type="Anticipated">March 2025</completion_date>
  <primary_completion_date type="Actual">September 23, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with major adverse cardiac events</measure>
    <time_frame>30-day after surgery</time_frame>
    <description>A composite of myocardial injury/infarction, new-onset clinically important arrhythmia, heart failure, stroke, cardiac arrest, and all-cause death after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with non-cardiovascular complications</measure>
    <time_frame>30-day after surgery</time_frame>
    <description>Postoperative acute kidney injury, infection, pulmonary complications, delirium, gastrointestinal complications (GI infarction, bleeding, perforation, obstruction), venous thromboembolism, anastomotic fistula, bleed requiring transfusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days alive and at home</measure>
    <time_frame>30-day after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants who died or developed disability</measure>
    <time_frame>180-day after surgery</time_frame>
    <description>Disability is assessed based on 12-item WHO Disability Assessment Schedule (WHODAS 2.0)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>For patients receiving radical cancer resection: overall survival</measure>
    <time_frame>3-year after surgery</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>For patients receiving radical cancer resection: disease-free survival</measure>
    <time_frame>3-year after surgery</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1500</enrollment>
  <condition>Cardiovascular Complication</condition>
  <arm_group>
    <arm_group_label>Intensive intraoperative blood pressure management</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional intraoperative blood pressure management</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intensive intraoperative blood pressure management</intervention_name>
    <description>Targeting intraoperative mean arterial pressure ≥ 80 mmHg.</description>
    <arm_group_label>Intensive intraoperative blood pressure management</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional intraoperative blood pressure management</intervention_name>
    <description>Targeting intraoperative mean arterial pressure ≥ 65 mmHg or 60% of the baseline level (use the higher target).</description>
    <arm_group_label>Conventional intraoperative blood pressure management</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged ≥ 45 years;&#xD;
&#xD;
          2. Undergoing major abdominal surgery under general anesthesia (expected surgery time&#xD;
             &gt;2h, expected length of postoperative stay &gt;2d);&#xD;
&#xD;
          3. Fulfill ≥1 of the following criteria (a-f): a. history of coronary artery disease; b.&#xD;
             history of stroke; c. history of peripheral arterial disease; d. history of congestive&#xD;
             heart failure; e. preoperative NT-proBNP &gt;200 pg/mL or BNP &gt;92 mg/L f. preoperative&#xD;
             troponin &gt; upper limit of normal; or fulfill ≥2 of the following criteria (g-l); g.&#xD;
             history of chronic kidney disease (preoperative sCr &gt;133μmol/L or 1.5 mg/dL); h.&#xD;
             diabetes requiring medical treatment; i. smoking in the past &gt;2 years; j.≥ 65 years of&#xD;
             age; k. hypertension requiring medical treatment l. history of hypercholesterolemia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. ASA score ≥5;&#xD;
&#xD;
          2. Severe untreated or uncontrolled hypertension (preoperative SBP&gt;180mmHg and/or&#xD;
             DBP&gt;110mmHg);&#xD;
&#xD;
          3. End-stage renal disease requiring renal-replacement therapy;&#xD;
&#xD;
          4. Acute cardiovascular event within 1 month of surgery, including acute heart failure,&#xD;
             acute coronary syndrome and stroke;&#xD;
&#xD;
          5. Preoperative sepsis or septic shock;&#xD;
&#xD;
          6. Preoperative requirement of vasopressor infusion;&#xD;
&#xD;
          7. Current participation in another interventional study;&#xD;
&#xD;
          8. Previous participation in this study;&#xD;
&#xD;
          9. Pregnant or breastfeeding women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bingcheng Zhao, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nanfang Hospital, Southern Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Xinqiao Hospital of Chongqing</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400037</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Medical University Nanfang Hospital</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henan Provincial People's Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>April 6, 2023</last_update_submitted>
  <last_update_submitted_qc>April 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intraoperative blood pressure</keyword>
  <keyword>Major abdominal surgery</keyword>
  <keyword>Cardiovascular complication</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The deidentified IPD will be shared upon reasonable request after study completion.</ipd_description>
  </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/NCT04430920
org study id: NFEC-2019-261
nct id: NCT04430920
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is a multicenter randomized controlled trial comparing an intensive intraoperative
      blood pressure management strategy versus conventional practice for preventing cardiovascular
      events in high-risk patients undergoing major abdominal surgery.
Intraoperative hypotension has been associated with cardiovascular events after non-cardiac
      surgery. However, whether avoiding intraoperative hypotension can reduce the incidence of
      postoperative cardiovascular events remains unclear. The objective of this study is to assess
      the effects of an intensive intraoperative blood pressure management strategy (to maintain
      intraoperative MAP ≥ 80mmHg) with that of conventional practice (to maintain intraoperative
      MAP ≥ 65mmHg) on the incidence of cardiovascular events after major abdominal surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Number of participants with major adverse cardiac events
time frame: 30-day after surgery
description: A composite of myocardial injury/infarction, new-onset clinically important arrhythmia, heart failure, stroke, cardiac arrest, and all-cause death after surgery
measure: Number of participants with non-cardiovascular complications
time frame: 30-day after surgery
description: Postoperative acute kidney injury, infection, pulmonary complications, delirium, gastrointestinal complications (GI infarction, bleeding, perforation, obstruction), venous thromboembolism, anastomotic fistula, bleed requiring transfusion
measure: Days alive and at home
time frame: 30-day after surgery
measure: Number of participants who died or developed disability
time frame: 180-day after surgery
description: Disability is assessed based on 12-item WHO Disability Assessment Schedule (WHODAS 2.0)
measure: For patients receiving radical cancer resection: overall survival
time frame: 3-year after surgery
measure: For patients receiving radical cancer resection: disease-free survival
time frame: 3-year after surgery
arm group label: Intensive intraoperative blood pressure management
arm group type: Active Comparator
arm group label: Conventional intraoperative blood pressure management
arm group type: Placebo Comparator
intervention type: Other
intervention name: Intensive intraoperative blood pressure management
description: Targeting intraoperative mean arterial pressure ≥ 80 mmHg.
arm group label: Intensive intraoperative blood pressure management
intervention type: Other
intervention name: Conventional intraoperative blood pressure management
description: Targeting intraoperative mean arterial pressure ≥ 65 mmHg or 60% of the baseline level (use the higher target).
arm group label: Conventional intraoperative blood pressure management
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: No
last name: Bingcheng Zhao, MD
role: Principal Investigator
affiliation: Nanfang Hospital, Southern Medical University
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor
sharing ipd: Yes
ipd description: The deidentified IPD will be shared upon reasonable request after study completion.