<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/NCT03243279</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00083136</org_study_id>
    <nct_id>NCT03243279</nct_id>
  </id_info>
  <brief_title>BRS and Outcomes in Cardiothoracic Surgery</brief_title>
  <official_title>Role of Preoperative Baroreflex Sensitivity on Major Outcomes After Cardiothoracic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of this study is to determine whether baroreceptor sensitivity (the ability of&#xD;
      your body to change your heart rate and/or blood pressure in response to a situation) has any&#xD;
      effect on how likely you are to suffer certain events after heart or lung surgery. The&#xD;
      postoperative events that the investigators will be studying are pain after surgery, atrial&#xD;
      fibrillation (an irregular heart rhythm), and cognitive dysfunction (a decline in mental&#xD;
      abilities).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to determine if preoperative baroreceptor sensitivity (BRS)&#xD;
      correlates with major outcomes after cardiac and thoracic surgery, including acute and&#xD;
      chronic pain, atrial arrhythmias, and cognitive function. To test this hypothesis,&#xD;
      approximately 95 patients will be enrolled, and spontaneous baroreceptor sensitivity will be&#xD;
      measured prior to surgery as well as immediately postoperatively. Outcomes will include acute&#xD;
      pain using the numeric rating scale, Brief Pain Inventory, and Gracely Box Scale administered&#xD;
      preoperatively, on postoperative days 1 and 2 and by phone at 6-weeks postoperatively.&#xD;
      Chronic pain will be assessed at 6-month follow-up visit via hyperalgesia testing using Von&#xD;
      Frey filaments. Postoperative atrial arrhythmias will be assessed by review of postoperative&#xD;
      telemetry, the electronic medical record, and ECG performed prior to discharge. Finally,&#xD;
      cognitive function will be assess via Mini-Mental State examination administered preoperative&#xD;
      and at the 6-month follow-up visit. Association between BRS and the outcomes of interest will&#xD;
      be tested with regression models adjusted for appropriate covariates. Significance threshold&#xD;
      alpha will be adjusted for the number of statistical tests using the Bonferroni correction.&#xD;
      Our hypothesis is that patients with impaired preoperative BRS will have an increased&#xD;
      incidence of acute and chronic postoperative pain, atrial fibrillation, and cognitive decline&#xD;
      after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2017</start_date>
  <completion_date type="Actual">May 31, 2022</completion_date>
  <primary_completion_date type="Actual">December 15, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Baseline baroreflex sensitivity</measure>
    <time_frame>30 min</time_frame>
    <description>Non-invasive BRS testing with BIOPAC MP160</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative day (POD) 1 baroreflex sensitivity</measure>
    <time_frame>30 min</time_frame>
    <description>Non-invasive BRS testing with BIOPAC MP160</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>POD 2 baroreflex sensitivity</measure>
    <time_frame>30 min</time_frame>
    <description>Non-invasive BRS testing with BIOPAC MP160</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6 month baroreflex sensitivity</measure>
    <time_frame>6 months</time_frame>
    <description>Non-invasive BRS testing with BIOPAC MP160</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute postoperative pain as assessed by the numeric rating scale (NRS) - 24h</measure>
    <time_frame>24 hours</time_frame>
    <description>Median NRS pain score in the first 24h after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute postoperative pain as assessed by the numeric rating scale (NRS) - 48h</measure>
    <time_frame>48 hours</time_frame>
    <description>Median NRS pain score in the second 24h after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute postoperative pain as assessed by the Gracely Box Scale (GBS) - POD1</measure>
    <time_frame>15 min</time_frame>
    <description>GBS survey on POD 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute postoperative pain as assessed by the Gracely Box Scale (GBS) - POD2</measure>
    <time_frame>15 min</time_frame>
    <description>GBS survey on POD 2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute postoperative pain as assessed by the Gracely Box Scale (GBS) - 6 mo</measure>
    <time_frame>6 months</time_frame>
    <description>GBS survey at 6 month follow-up visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chronic pain as assessed by the change in Brief Pain Inventory score</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>Change from baseline to 6 months postoperatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hyperalgesia</measure>
    <time_frame>6 months</time_frame>
    <description>Nociceptive threshold as assessed by Von Frey filament testing at 6 month follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area of hyperalgesia or allodynia</measure>
    <time_frame>6 months</time_frame>
    <description>Area surrounding operative incision as assessed by Von Frey filament testing at 6 month follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative atrial fibrillation</measure>
    <time_frame>6 weeks</time_frame>
    <description>Chart review assessment of the occurrence of postoperative atrial fibrillation during hospitalization and up to 6 weeks postoperatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative cognitive change</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>Change from baseline to 6 months in the Mini Mental Status Exam score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline psychological distress</measure>
    <time_frame>15 min</time_frame>
    <description>As assessed by the Brief Symptom Inventory-18</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6 month psychological distress</measure>
    <time_frame>6 months</time_frame>
    <description>As assessed by the Brief Symptom Inventory-18</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline frailty</measure>
    <time_frame>10 min</time_frame>
    <description>As assessed by the Modified Frailty Index</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">72</enrollment>
  <condition>Pain, Postoperative</condition>
  <condition>Atrial Fibrillation</condition>
  <condition>Cognitive Dysfunction</condition>
  <arm_group>
    <arm_group_label>Surgical</arm_group_label>
    <description>No interventions. Patients undergoing cardiothoracic surgery will be assessed for baroreflex sensitivity and the outcomes of interest.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Arterial blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All patients presenting for cardiac and thoracic surgery at Duke University Hospital, a&#xD;
        quaternary referral center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;= 18 years of age&#xD;
&#xD;
          -  Undergoing cardiac (coronary artery bypass grafting [CABG], CABG + valve, or valve&#xD;
             only) or thoracic (video-assisted thoracoscopic [VATS] approach to lobectomy) surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any preexisting pain condition (defined as pain of &gt;=3 months duration prior to&#xD;
             enrollment)&#xD;
&#xD;
          -  Pain at the time of enrollment interview&#xD;
&#xD;
          -  Need for preoperative analgesics&#xD;
&#xD;
          -  Preexisting chronic or paroxysmal atrial fibrillation&#xD;
&#xD;
          -  Preexisting atrial or ventricular arrhythmia&#xD;
&#xD;
          -  Need for preoperative anti-arrhythmic medication&#xD;
&#xD;
          -  History of symptomatic cerebrovascular disease (e.g., prior stroke) with residual&#xD;
             deficits&#xD;
&#xD;
          -  Alcoholism (&gt;2 drinks/day)&#xD;
&#xD;
          -  Psychiatric illness (any clinical diagnosis requiring therapy)&#xD;
&#xD;
          -  Drug abuse (any illicit drug use in the preceding 3 months before surgery)&#xD;
&#xD;
          -  Hepatic insufficiency (liver function tests &gt; 1.5 times the upper limit of normal)&#xD;
&#xD;
          -  Severe pulmonary insufficiency (home oxygen)&#xD;
&#xD;
          -  Renal failure (serum creatinine &gt;2.0 mg/dL)&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  Unable to read&#xD;
&#xD;
          -  Participants who score &lt;24 on baseline Mini Mental State examination&#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>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>July 20, 2022</last_update_submitted>
  <last_update_submitted_qc>July 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <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/NCT03243279
org study id: Pro00083136
nct id: NCT03243279
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine whether baroreceptor sensitivity (the ability of
      your body to change your heart rate and/or blood pressure in response to a situation) has any
      effect on how likely you are to suffer certain events after heart or lung surgery. The
      postoperative events that the investigators will be studying are pain after surgery, atrial
      fibrillation (an irregular heart rhythm), and cognitive dysfunction (a decline in mental
      abilities).
The purpose of this study is to determine if preoperative baroreceptor sensitivity (BRS)
      correlates with major outcomes after cardiac and thoracic surgery, including acute and
      chronic pain, atrial arrhythmias, and cognitive function. To test this hypothesis,
      approximately 95 patients will be enrolled, and spontaneous baroreceptor sensitivity will be
      measured prior to surgery as well as immediately postoperatively. Outcomes will include acute
      pain using the numeric rating scale, Brief Pain Inventory, and Gracely Box Scale administered
      preoperatively, on postoperative days 1 and 2 and by phone at 6-weeks postoperatively.
      Chronic pain will be assessed at 6-month follow-up visit via hyperalgesia testing using Von
      Frey filaments. Postoperative atrial arrhythmias will be assessed by review of postoperative
      telemetry, the electronic medical record, and ECG performed prior to discharge. Finally,
      cognitive function will be assess via Mini-Mental State examination administered preoperative
      and at the 6-month follow-up visit. Association between BRS and the outcomes of interest will
      be tested with regression models adjusted for appropriate covariates. Significance threshold
      alpha will be adjusted for the number of statistical tests using the Bonferroni correction.
      Our hypothesis is that patients with impaired preoperative BRS will have an increased
      incidence of acute and chronic postoperative pain, atrial fibrillation, and cognitive decline
      after surgery.
observational model: Cohort
time perspective: Prospective
measure: Baseline baroreflex sensitivity
time frame: 30 min
description: Non-invasive BRS testing with BIOPAC MP160
measure: Postoperative day (POD) 1 baroreflex sensitivity
time frame: 30 min
description: Non-invasive BRS testing with BIOPAC MP160
measure: POD 2 baroreflex sensitivity
time frame: 30 min
description: Non-invasive BRS testing with BIOPAC MP160
measure: 6 month baroreflex sensitivity
time frame: 6 months
description: Non-invasive BRS testing with BIOPAC MP160
measure: Acute postoperative pain as assessed by the numeric rating scale (NRS) - 24h
time frame: 24 hours
description: Median NRS pain score in the first 24h after surgery
measure: Acute postoperative pain as assessed by the numeric rating scale (NRS) - 48h
time frame: 48 hours
description: Median NRS pain score in the second 24h after surgery
measure: Acute postoperative pain as assessed by the Gracely Box Scale (GBS) - POD1
time frame: 15 min
description: GBS survey on POD 1
measure: Acute postoperative pain as assessed by the Gracely Box Scale (GBS) - POD2
time frame: 15 min
description: GBS survey on POD 2
measure: Acute postoperative pain as assessed by the Gracely Box Scale (GBS) - 6 mo
time frame: 6 months
description: GBS survey at 6 month follow-up visit
measure: Chronic pain as assessed by the change in Brief Pain Inventory score
time frame: Baseline, 6 months
description: Change from baseline to 6 months postoperatively
measure: Hyperalgesia
time frame: 6 months
description: Nociceptive threshold as assessed by Von Frey filament testing at 6 month follow-up
measure: Area of hyperalgesia or allodynia
time frame: 6 months
description: Area surrounding operative incision as assessed by Von Frey filament testing at 6 month follow-up
measure: Postoperative atrial fibrillation
time frame: 6 weeks
description: Chart review assessment of the occurrence of postoperative atrial fibrillation during hospitalization and up to 6 weeks postoperatively
measure: Postoperative cognitive change
time frame: Baseline, 6 months
description: Change from baseline to 6 months in the Mini Mental Status Exam score
measure: Baseline psychological distress
time frame: 15 min
description: As assessed by the Brief Symptom Inventory-18
measure: 6 month psychological distress
time frame: 6 months
description: As assessed by the Brief Symptom Inventory-18
measure: Baseline frailty
time frame: 10 min
description: As assessed by the Modified Frailty Index
arm group label: Surgical
description: No interventions. Patients undergoing cardiothoracic surgery will be assessed for baroreflex sensitivity and the outcomes of interest.
Arterial blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Pain, Postoperative
mesh term: Cognitive Dysfunction
sharing ipd: Undecided