Leukocyte FunctionNCT02207842
The Determination of the Effect of Volatile Anesthetics on Leukocyte Function ex Vivo
An observational study of Leukocyte Function and Anesthesia, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 months and older
- Conditions the study is for
- Leukocyte Function, Anesthesia
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Male and female patients
- greater than or equal to 12 months of age
- scheduled for a cardiac catheterization, cardiac surgery, or cardiac MRI
Who cannot join
- known underlying hematological disorder
- known oncological disorder
- patients who do not require preoperative laboratory testing
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
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.
- Conditions
- Leukocyte Function, Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Volatile anesthesia exposure | Not described | |
| No volatile anesthesia exposure | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leukocyte function under anesthesia
The study will evaluate ex vivo leukocyte function by testing leukocyte activation, TNF-a production, and phagocytic function in the laboratory.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2014 (estimated)
- Study startNov 2014
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukocyte FunctionStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Koichi Yuki, Boston Children's Hospital
- Investigators
- Koichi Yuki, M.D., Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02207842
- Sponsor's protocol ID
- P00012751
- Status last verified
- Apr 2017
- First submitted
- 30 Jul 2014
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Determination of the Effect of Volatile Anesthetics on Leukocyte Function ex Vivo
- ClinicalTrials.gov ID
- NCT02207842
- Acronym / sponsor ID
- P00012751
- Conditions
- Leukocyte Function, Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 4 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volatile anesthesia exposure | – | – |
| No volatile anesthesia exposure | – | – |
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Male and female patients
- greater than or equal to 12 months of age
- scheduled for a cardiac catheterization, cardiac surgery, or cardiac MRI
Key exclusion criteria (3 listed)
- known underlying hematological disorder
- known oncological disorder
- patients who do not require preoperative laboratory testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Koichi Yuki, M.D. principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukocyte Function and Anesthesia, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leukocyte function under anesthesia (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2017.