<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/NCT01683448</url>
  </required_header>
  <id_info>
    <org_study_id>298807</org_study_id>
    <nct_id>NCT01683448</nct_id>
  </id_info>
  <brief_title>The Effect of Perioperative Medications on the Outcomes of Patients Undergoing Cardiac Surgery</brief_title>
  <official_title>The Effect of Perioperative Medications on the Outcomes of Patients Undergoing Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Davis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be a retrospective study. The patient data from the electronic medical&#xD;
      records and existing database will be collected and analyzed. Primary endpoints will be&#xD;
      postoperative mortality (within 30 days) and overall complications and length of hospital&#xD;
      stay. The secondary endpoints will be myocardial infarction, cardiac death, CHF, arrhythmia,&#xD;
      ischemia, stroke, neurological complications, length of ICU stay, re-admission rate,&#xD;
      infections, pulmonary complications, length of intubation time, length of ventilation time,&#xD;
      and acute renal failure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each year about 694,000 Americans have open-heart surgery including valve repairs, valve&#xD;
      replacements, heart transplants, and coronary artery bypass graft (CABG) surgery [1]. The&#xD;
      reported incidence of perioperative complications in these cardiac surgery patients is 4.5%&#xD;
      while the prevalence varied from1.6% to 14.1% [2,3]. As the population ages, increased&#xD;
      numbers of elderly patients with more advanced cardiac diseases and comorbidities are being&#xD;
      referred for cardiac surgery. For these patients, postoperative cardiovascular complications&#xD;
      (cardiac death, myocardial infarction (MI), ischemia, congestive heart failure (CHF),&#xD;
      arrhythmia, stroke, and acute renal failure (ARF)) represent the major postoperative&#xD;
      complications [4-6]. These complications translate into increased mortality, prolonged&#xD;
      hospital stay and estimated costs exceeding $20 billion annually [7].&#xD;
&#xD;
      These events may be triggered by surgical stress responses that result in increased plasma&#xD;
      levels of norepinephrine and epinephrine [8], myocardial oxygen supply demand imbalance, and&#xD;
      plaque rupture [9].&#xD;
&#xD;
      Beta-blockers, ACE inhibitors, alfa2-agonists, Aspirin, statins, nitrates, anti-platelet&#xD;
      medications and anticoagulation medications have been widely used in patients with coronary&#xD;
      artery disease, hypertension and other heart diseases. Beta-blockers, ACE inhibitors and&#xD;
      Aspirin statins have also been shown to have a positive impact on the outcomes of surgical&#xD;
      and non-surgical treatments [10-11]. However, there are other studies which were unable to&#xD;
      demonstrate the positive results of these medications on post-operative outcomes.&#xD;
&#xD;
      Based on the previous studies referenced above, we propose that the use of perioperative&#xD;
      medications (Betablockers, ACE inhibitors, alfa2-agonists, Aspirin, statins, nitrates,&#xD;
      anti-platelet medications, and anticoagulation medications) may provide cardiac protection&#xD;
      for cardiac surgical patients. The specific aim of this study is to retrospectively&#xD;
      investigate whether perioperative medication use is associated with decreases in the&#xD;
      incidence of postoperative cardiovascular complications in patients undergoing elective&#xD;
      cardiac surgery.&#xD;
&#xD;
      This study will be a retrospective study. The patient data from the electronic medical&#xD;
      records and existing database will be collected and analyzed. Primary endpoints will be&#xD;
      postoperative mortality (within 30 days) and overall complications and length of hospital&#xD;
      stay. The secondary endpoints will be myocardial infarction, cardiac death, CHF, arrhythmia,&#xD;
      ischemia, stroke, neurological complications, length of ICU stay, re-admission rate,&#xD;
      infections, pulmonary complications, length of intubation time, length of ventilation time,&#xD;
      and acute renal failure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2010</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>hemodynamic changes</measure>
    <time_frame>In hospital</time_frame>
    <description>blood pressure and heart rare</description>
  </primary_outcome>
  <enrollment type="Actual">1</enrollment>
  <condition>Cardiac Diseases</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Cardiac surgical patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All cardiac surgical patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non cardiac surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hong Liu, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>UC Davis, Department of Anesthesiology and Pain Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UC Davis, Medical Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>December 1, 2020</last_update_submitted>
  <last_update_submitted_qc>December 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Perioperative medications</keyword>
  <keyword>cardiac surgery</keyword>
  <keyword>outcomes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</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/NCT01683448
org study id: 298807
nct id: NCT01683448
lead sponsor: 
has dmc: No
This study will be a retrospective study. The patient data from the electronic medical
      records and existing database will be collected and analyzed. Primary endpoints will be
      postoperative mortality (within 30 days) and overall complications and length of hospital
      stay. The secondary endpoints will be myocardial infarction, cardiac death, CHF, arrhythmia,
      ischemia, stroke, neurological complications, length of ICU stay, re-admission rate,
      infections, pulmonary complications, length of intubation time, length of ventilation time,
      and acute renal failure.
Each year about 694,000 Americans have open-heart surgery including valve repairs, valve
      replacements, heart transplants, and coronary artery bypass graft (CABG) surgery [1]. The
      reported incidence of perioperative complications in these cardiac surgery patients is 4.5%
      while the prevalence varied from1.6% to 14.1% [2,3]. As the population ages, increased
      numbers of elderly patients with more advanced cardiac diseases and comorbidities are being
      referred for cardiac surgery. For these patients, postoperative cardiovascular complications
      (cardiac death, myocardial infarction (MI), ischemia, congestive heart failure (CHF),
      arrhythmia, stroke, and acute renal failure (ARF)) represent the major postoperative
      complications [4-6]. These complications translate into increased mortality, prolonged
      hospital stay and estimated costs exceeding $20 billion annually [7].

      These events may be triggered by surgical stress responses that result in increased plasma
      levels of norepinephrine and epinephrine [8], myocardial oxygen supply demand imbalance, and
      plaque rupture [9].

      Beta-blockers, ACE inhibitors, alfa2-agonists, Aspirin, statins, nitrates, anti-platelet
      medications and anticoagulation medications have been widely used in patients with coronary
      artery disease, hypertension and other heart diseases. Beta-blockers, ACE inhibitors and
      Aspirin statins have also been shown to have a positive impact on the outcomes of surgical
      and non-surgical treatments [10-11]. However, there are other studies which were unable to
      demonstrate the positive results of these medications on post-operative outcomes.

      Based on the previous studies referenced above, we propose that the use of perioperative
      medications (Betablockers, ACE inhibitors, alfa2-agonists, Aspirin, statins, nitrates,
      anti-platelet medications, and anticoagulation medications) may provide cardiac protection
      for cardiac surgical patients. The specific aim of this study is to retrospectively
      investigate whether perioperative medication use is associated with decreases in the
      incidence of postoperative cardiovascular complications in patients undergoing elective
      cardiac surgery.

      This study will be a retrospective study. The patient data from the electronic medical
      records and existing database will be collected and analyzed. Primary endpoints will be
      postoperative mortality (within 30 days) and overall complications and length of hospital
      stay. The secondary endpoints will be myocardial infarction, cardiac death, CHF, arrhythmia,
      ischemia, stroke, neurological complications, length of ICU stay, re-admission rate,
      infections, pulmonary complications, length of intubation time, length of ventilation time,
      and acute renal failure.
observational model: Cohort
time perspective: Retrospective
measure: hemodynamic changes
time frame: In hospital
description: blood pressure and heart rare
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hong Liu, M.D.
role: Principal Investigator
affiliation: UC Davis, Department of Anesthesiology and Pain Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Heart Diseases