- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02207842
The Determination of the Effect of Volatile Anesthetics on Leukocyte Function ex Vivo
April 28, 2017 updated by: Koichi Yuki, Boston Children's Hospital
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
41
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Boston Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Male and female patients greater than or equal to 12 months of age, who present for a cardiac catheterization, cardiac surgery, or cardiac MRI at Boston Children's Hospital.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Volatile anesthesia exposure
|
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No volatile anesthesia exposure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Leukocyte function under anesthesia
Time Frame: 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.
|
up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Koichi Yuki, M.D., Boston Children's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
July 30, 2014
First Submitted That Met QC Criteria
August 1, 2014
First Posted (Estimate)
August 4, 2014
Study Record Updates
Last Update Posted (Actual)
May 1, 2017
Last Update Submitted That Met QC Criteria
April 28, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- P00012751
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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