<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/NCT04458701</url>
  </required_header>
  <id_info>
    <org_study_id>5170287</org_study_id>
    <nct_id>NCT04458701</nct_id>
  </id_info>
  <brief_title>Prospective Data Analysis of a Quality Improvement Initiative in High Risk Cardiac Surgery Patients</brief_title>
  <official_title>Prospective Data Analysis of a Quality Improvement Initiative for Perioperative Hemodynamic Optimization Therapy and Postoperative Outcomes in Patients Undergoing High-Risk Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Loma Linda University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Edwards Lifesciences</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Loma Linda University</source>
  <oversight_info>
    <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>
      This project is designed to assess the impact of implementing a hemodynamic optimization&#xD;
      protocol, utilizing flow guided parameters that is provided by technology from Edwards&#xD;
      Lifesciences, for patients undergoing high risk cardiac surgery. Importantly, this project is&#xD;
      being targeted as a QI initiative because there is no evaluation of new technology or&#xD;
      procedures. All technologies and procedures are currently being used for patients undergoing&#xD;
      cardiac surgery. Rather this project is evaluating the implementation of a multi-dispclinary&#xD;
      developed protocol that seeks to remove variability in which providers are currently treating&#xD;
      patients hemodynamics during and acutely after cardiac surgery. Previous research has&#xD;
      demonstrated that implementation of hemodynamic management protocols improves perioperative&#xD;
      outcome in surgical patients. This project seeks to evaluate the impact of implementing this&#xD;
      protocol as the new clinical standard for high-risk cardiac surgery patients. Specifically,&#xD;
      this protocol would be a comprehensive hemodynamic management strategy that would-be&#xD;
      initiated in the operating room post-bypass and then continued for the first 12 hours in the&#xD;
      intensive care unit (see figure below). To restate, all technologies and procedures are&#xD;
      currently being performed for these patients, however, there has not been a protocol guiding&#xD;
      how practionioners use this technology. The project is evaluating the impact of protocolized&#xD;
      treatment strategies. Importantly this protocol has been designed, reviewed and agreed by the&#xD;
      motivation of the physicians who are currently responsible for managing these patients&#xD;
      hemodynamics. Since this project does involve alterations in procedures or technologies we&#xD;
      are seeking to proceed as a quality improvement project. Additionally the protocol is one&#xD;
      that has been reviewed and agreed to provide the optimal management strategy for these&#xD;
      patients. This again is the overall focus of this project, to implement a hemodynamic&#xD;
      management protocol to improve outcomes in patients undergoing cardiac surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 17, 2019</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">February 1, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Length of Stay</measure>
    <time_frame>days</time_frame>
    <description>ICU length of stay</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major postoperative complications identified as:</measure>
    <time_frame>during hospitalization</time_frame>
    <description>1) incidence of stroke, (2) incidence of renal failure (defined as a threefold or greater rise in creatinine or new dialysis requirement), (3) prolonged intubation (&gt;24 hours), and/or (4) a sternal wound infection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-day readmission</measure>
    <time_frame>days</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">195</enrollment>
  <condition>Coronary Artery Bypass Graft</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hemodynamic monitoring</intervention_name>
    <description>This is a comprehensive hemodynamic management strategy that would-be initiated in the operating room post-bypass and then continued for the first 12 hours in the intensive care unit</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All adult high risk cardiac surgical patients undergoing procedures requiring&#xD;
        cardiopulmonary bypass. High risk was defined, a priori, as patients who are expected to&#xD;
        require an inotropic and/or vasoconstrictive agent for more than 12 hours post-CPB.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        (1) the procedure was a first-start case, (2) the procedure was scheduled, (3) the&#xD;
        procedure is considered non-emergent, and (4) the cardiac surgery required cardiopulmonary&#xD;
        bypass&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        (1) Patients less than 18 years of age, (2) failure to undergo CPB, (3) non-first-start or&#xD;
        emergent classification, (4) as well those who did not receive at least 12 hours of&#xD;
        inotropic and/or vasoconstrictive agents were excluded from the study.&#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>Davinder Ramsingh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Loma Linda University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Loma Linda University Medical Center</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92354</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>August 27, 2020</last_update_submitted>
  <last_update_submitted_qc>August 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Loma Linda University</investigator_affiliation>
    <investigator_full_name>Davinder Ramsingh, MD</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT04458701
org study id: 5170287
nct id: NCT04458701
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This project is designed to assess the impact of implementing a hemodynamic optimization
      protocol, utilizing flow guided parameters that is provided by technology from Edwards
      Lifesciences, for patients undergoing high risk cardiac surgery. Importantly, this project is
      being targeted as a QI initiative because there is no evaluation of new technology or
      procedures. All technologies and procedures are currently being used for patients undergoing
      cardiac surgery. Rather this project is evaluating the implementation of a multi-dispclinary
      developed protocol that seeks to remove variability in which providers are currently treating
      patients hemodynamics during and acutely after cardiac surgery. Previous research has
      demonstrated that implementation of hemodynamic management protocols improves perioperative
      outcome in surgical patients. This project seeks to evaluate the impact of implementing this
      protocol as the new clinical standard for high-risk cardiac surgery patients. Specifically,
      this protocol would be a comprehensive hemodynamic management strategy that would-be
      initiated in the operating room post-bypass and then continued for the first 12 hours in the
      intensive care unit (see figure below). To restate, all technologies and procedures are
      currently being performed for these patients, however, there has not been a protocol guiding
      how practionioners use this technology. The project is evaluating the impact of protocolized
      treatment strategies. Importantly this protocol has been designed, reviewed and agreed by the
      motivation of the physicians who are currently responsible for managing these patients
      hemodynamics. Since this project does involve alterations in procedures or technologies we
      are seeking to proceed as a quality improvement project. Additionally the protocol is one
      that has been reviewed and agreed to provide the optimal management strategy for these
      patients. This again is the overall focus of this project, to implement a hemodynamic
      management protocol to improve outcomes in patients undergoing cardiac surgery.
observational model: Case-Only
time perspective: Prospective
measure: Length of Stay
time frame: days
description: ICU length of stay
measure: Major postoperative complications identified as:
time frame: during hospitalization
description: 1) incidence of stroke, (2) incidence of renal failure (defined as a threefold or greater rise in creatinine or new dialysis requirement), (3) prolonged intubation (>24 hours), and/or (4) a sternal wound infection.
measure: Hospital length of stay
time frame: days
measure: 30-day readmission
time frame: days
intervention type: Device
intervention name: Hemodynamic monitoring
description: This is a comprehensive hemodynamic management strategy that would-be initiated in the operating room post-bypass and then continued for the first 12 hours in the intensive care unit
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Davinder Ramsingh, MD
role: Principal Investigator
affiliation: Loma Linda University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Loma Linda University
investigator full name: Davinder Ramsingh, MD
investigator title: MD
sharing ipd: No