<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/NCT02244034</url>
  </required_header>
  <id_info>
    <org_study_id>SI002</org_study_id>
    <nct_id>NCT02244034</nct_id>
  </id_info>
  <brief_title>Incidence and Risk Factors of Postoperative Hypothermia in Cardiac Surgery</brief_title>
  <official_title>Incidence and Risk Factors of Postoperative Hypothermia in Patients With Cardiopulmonary Bypass.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mahidol University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Postoperative hypothermia may result in relevant complications such as adverse&#xD;
      cardiovascular events, wound infection, and coagulopathy with consecutive blood loss.&#xD;
      Patients with open cardiac surgery using cardiopulmonary bypass are particular at risk for&#xD;
      hypothermia. The study of Karalapillai and coworkers, analyzing a huge database incl. 43,158&#xD;
      patients with CPB, revealed 66% of them experiencing postoperative hypothermia during the&#xD;
      first 24 hours and 0.3% longer than that. During cardiac surgery great parts of body surface&#xD;
      including wound surface are exposed. Many of these patients receive large amounts of&#xD;
      infusions and transfusions, and undergo hemodilution during CPB, which may additionally&#xD;
      contribute to development of hypothermia.&#xD;
&#xD;
      Objective of the planned study is to find out incidence and duration of postoperative&#xD;
      hypothermia and also risk factors for hypothermia in cardiac patients. Further objective is&#xD;
      the incidence of postoperative complications and its relation to postoperative core&#xD;
      temperature.&#xD;
&#xD;
      Methods: A retrospective chart review 780 patients who had been underwent cardiac surgery&#xD;
      with CPB Included are patients ≥ 18 years old. Excluded are patients with preoperative&#xD;
      hyperthermia (&gt; 37.8 °C) and hypothermia (&gt; 36 °C).&#xD;
&#xD;
      The following parameters will be recorded: temperature is measured at ICU after arrived and&#xD;
      after 6 hours which is primary outcome, biometric data include age, sex, body weight, height,&#xD;
      ASA physical status, surgical procedure includes emergency cases, anesthetic and surgical&#xD;
      (bypass-) times, infusion/transfusion-regimen, blood loss and urine output, coolest&#xD;
      temperature during bypass, method of temperature protection, and the outcome of operation .&#xD;
&#xD;
      All data will be described in number and percent and Pearson chi-square method will be used&#xD;
      for analyze correlation between hypothermia and risk factor . P-value &lt;0.05 will be defined&#xD;
      to significant.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2013</start_date>
  <completion_date type="Actual">December 31, 2013</completion_date>
  <primary_completion_date type="Actual">December 31, 2013</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>incidence of postoperative hypothermia in patients with cardiopulmonary bypass.</measure>
    <time_frame>24 hours</time_frame>
    <description>Upon arrival at the Cardiac Surgical Intensive Care Unit (CSICU), body temperature was measured using an infrared tympanic membrane thermometer. Postoperative hypothermia, which was defined as the body temperature &lt; 36 degrees C upon arrival at the CSICU.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>predictors of postoperative hypothermia in patients with cardiopulmonary bypass.</measure>
    <time_frame>24 hours</time_frame>
    <description>Predictors such as age, sex, body surface area, emergency surgery, time of operation, time of cardiopulmonary bypass time, fluid and blood component administer will be analyze.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">760</enrollment>
  <condition>Postoperative Hypothermia in Patients With Cardiopulmonary Bypass</condition>
  <arm_group>
    <arm_group_label>760 patients who underwent open cardiac and/or thoracic aortic surgery using CPB</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>hypothermia</intervention_name>
    <arm_group_label>760 patients who underwent open cardiac and/or thoracic aortic surgery using CPB</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients who had been underwent cardiac surgery with CPB during 2012-2013&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients ≥ 18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with preoperative hyperthermia (&gt; 37.8 °C) and hypothermia (&lt; 36 °C).&#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>Faculty of medicine Siriraj hospital</name>
      <address>
        <city>Bangkok</city>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <last_update_submitted>April 6, 2022</last_update_submitted>
  <last_update_submitted_qc>April 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mahidol University</investigator_affiliation>
    <investigator_full_name>Chaowanan Khamtuikrua</investigator_full_name>
    <investigator_title>instructor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypothermia</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/NCT02244034
org study id: SI002
nct id: NCT02244034
lead sponsor: 
has dmc: No
Background: Postoperative hypothermia may result in relevant complications such as adverse
      cardiovascular events, wound infection, and coagulopathy with consecutive blood loss.
      Patients with open cardiac surgery using cardiopulmonary bypass are particular at risk for
      hypothermia. The study of Karalapillai and coworkers, analyzing a huge database incl. 43,158
      patients with CPB, revealed 66% of them experiencing postoperative hypothermia during the
      first 24 hours and 0.3% longer than that. During cardiac surgery great parts of body surface
      including wound surface are exposed. Many of these patients receive large amounts of
      infusions and transfusions, and undergo hemodilution during CPB, which may additionally
      contribute to development of hypothermia.

      Objective of the planned study is to find out incidence and duration of postoperative
      hypothermia and also risk factors for hypothermia in cardiac patients. Further objective is
      the incidence of postoperative complications and its relation to postoperative core
      temperature.

      Methods: A retrospective chart review 780 patients who had been underwent cardiac surgery
      with CPB Included are patients ≥ 18 years old. Excluded are patients with preoperative
      hyperthermia (> 37.8 °C) and hypothermia (> 36 °C).

      The following parameters will be recorded: temperature is measured at ICU after arrived and
      after 6 hours which is primary outcome, biometric data include age, sex, body weight, height,
      ASA physical status, surgical procedure includes emergency cases, anesthetic and surgical
      (bypass-) times, infusion/transfusion-regimen, blood loss and urine output, coolest
      temperature during bypass, method of temperature protection, and the outcome of operation .

      All data will be described in number and percent and Pearson chi-square method will be used
      for analyze correlation between hypothermia and risk factor . P-value <0.05 will be defined
      to significant.
observational model: Cohort
time perspective: Retrospective
measure: incidence of postoperative hypothermia in patients with cardiopulmonary bypass.
time frame: 24 hours
description: Upon arrival at the Cardiac Surgical Intensive Care Unit (CSICU), body temperature was measured using an infrared tympanic membrane thermometer. Postoperative hypothermia, which was defined as the body temperature < 36 degrees C upon arrival at the CSICU.
measure: predictors of postoperative hypothermia in patients with cardiopulmonary bypass.
time frame: 24 hours
description: Predictors such as age, sex, body surface area, emergency surgery, time of operation, time of cardiopulmonary bypass time, fluid and blood component administer will be analyze.
arm group label: 760 patients who underwent open cardiac and/or thoracic aortic surgery using CPB
intervention type: Procedure
intervention name: hypothermia
arm group label: 760 patients who underwent open cardiac and/or thoracic aortic surgery using CPB
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Mahidol University
investigator full name: Chaowanan Khamtuikrua
investigator title: instructor
mesh term: Hypothermia