<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/NCT02207842</url>
  </required_header>
  <id_info>
    <org_study_id>P00012751</org_study_id>
    <nct_id>NCT02207842</nct_id>
  </id_info>
  <brief_title>The Determination of the Effect of Volatile Anesthetics on Leukocyte Function ex Vivo</brief_title>
  <official_title>The Determination of the Effect of Volatile Anesthetics on Leukocyte Function ex Vivo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      One of the most common side effects of a surgical procedure is infection. In order to lower&#xD;
      the number of infections that occur after surgery, it is important for physicians to know how&#xD;
      medications used during surgery affect the way the body fights infection. Often, when&#xD;
      anesthesiologists are helping people go to sleep before surgery they give people medications&#xD;
      known as &quot;volatile anesthetics&quot;. Volatile anesthetics are medications that can change from a&#xD;
      liquid or solid to a gas very easily. Some studies suggest that these types of medications&#xD;
      may change the way white blood cells work in the body. Changing the way white blood cells&#xD;
      work could possibly increase the person's risk of infection after their surgery or weaken&#xD;
      their body's ability to fight infections. The goal of this research study is to learn about&#xD;
      how volatile anesthesia medications change the way white blood cells work in people having&#xD;
      anesthesia for cardiac procedures. To do this, investigators will examine the function of&#xD;
      while blood cells in the laboratory based setting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</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>Leukocyte function under anesthesia</measure>
    <time_frame>up to 12 months</time_frame>
    <description>The study will evaluate ex vivo leukocyte function by testing leukocyte activation, TNF-a production, and phagocytic function in the laboratory.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">41</enrollment>
  <condition>Leukocyte Function</condition>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Volatile anesthesia exposure</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>No volatile anesthesia exposure</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Male and female patients greater than or equal to 12 months of age, who present for a&#xD;
        cardiac catheterization, cardiac surgery, or cardiac MRI at Boston Children's Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients&#xD;
&#xD;
          -  greater than or equal to 12 months of age&#xD;
&#xD;
          -  scheduled for a cardiac catheterization, cardiac surgery, or cardiac MRI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known underlying hematological disorder&#xD;
&#xD;
          -  known oncological disorder&#xD;
&#xD;
          -  patients who do not require preoperative laboratory testing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Koichi Yuki, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <last_update_submitted>April 28, 2017</last_update_submitted>
  <last_update_submitted_qc>April 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Koichi Yuki</investigator_full_name>
    <investigator_title>staff anesthesiologist</investigator_title>
  </responsible_party>
  <!-- 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/NCT02207842
org study id: P00012751
nct id: NCT02207842
lead sponsor: 
has dmc: No
One of the most common side effects of a surgical procedure is infection. In order to lower
      the number of infections that occur after surgery, it is important for physicians to know how
      medications used during surgery affect the way the body fights infection. Often, when
      anesthesiologists are helping people go to sleep before surgery they give people medications
      known as "volatile anesthetics". Volatile anesthetics are medications that can change from a
      liquid or solid to a gas very easily. Some studies suggest that these types of medications
      may change the way white blood cells work in the body. Changing the way white blood cells
      work could possibly increase the person's risk of infection after their surgery or weaken
      their body's ability to fight infections. The goal of this research study is to learn about
      how volatile anesthesia medications change the way white blood cells work in people having
      anesthesia for cardiac procedures. To do this, investigators will examine the function of
      while blood cells in the laboratory based setting.
observational model: Cohort
time perspective: Prospective
measure: Leukocyte function under anesthesia
time frame: up to 12 months
description: The study will evaluate ex vivo leukocyte function by testing leukocyte activation, TNF-a production, and phagocytic function in the laboratory.
arm group label: Volatile anesthesia exposure
arm group label: No volatile anesthesia exposure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Months
maximum age: N/A
healthy volunteers: No
last name: Koichi Yuki, M.D.
role: Principal Investigator
affiliation: Boston Children's Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Koichi Yuki
investigator title: staff anesthesiologist