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The Determination of the Effect of Volatile Anesthetics on Leukocyte Function ex Vivo

Sponsor
Boston Children's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02207842
Collaborator
(none)
41
Enrollment
1
Location
26
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    41 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Determination of the Effect of Volatile Anesthetics on Leukocyte Function ex Vivo
    Study Start Date :
    Nov 1, 2014
    Actual Primary Completion Date :
    Jan 1, 2017
    Actual Study Completion Date :
    Jan 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Volatile anesthesia exposure
    No volatile anesthesia exposure

    Outcome Measures

    Primary Outcome Measures

    1. Leukocyte function under anesthesia [up to 12 months]

      The study will evaluate ex vivo leukocyte function by testing leukocyte activation, TNF-a production, and phagocytic function in the laboratory.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Months and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male and female patients

    • greater than or equal to 12 months of age

    • scheduled for a cardiac catheterization, cardiac surgery, or cardiac MRI

    Exclusion Criteria:

    • known underlying hematological disorder

    • known oncological disorder

    • patients who do not require preoperative laboratory testing

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Boston Children's Hospital Boston Massachusetts United States 02115

    Sponsors and Collaborators

    • Boston Children's Hospital

    Investigators

    • Principal Investigator: Koichi Yuki, M.D., Boston Children's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Koichi Yuki, staff anesthesiologist, Boston Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT02207842
    Other Study ID Numbers:
    • P00012751
    First Posted:
    Aug 4, 2014
    Last Update Posted:
    May 1, 2017
    Last Verified:
    Apr 1, 2017

    Study Results

    No Results Posted as of May 1, 2017