SepsisNCT02361970
Study on the Role of Gamma Delta T Cells in Sepsis Immunosuppression and Its Molecular Mechanism
An observational study of Sepsis, run by West China Hospital at 1 site in China.
Trial summary
The purpose of the study is to evaluate the status and function of gamma delta T cells in peripheral blood of sepsis patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- May 2014to May 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients admitted in ICUs of West China Hospital
Who may be able to join
- clinical symptoms of severe sepsis and septic shock
- age over 18 years
Who cannot join
- preexisting autoimmune disease
- patients received immuno-suppressive treatment in the previous 6 months
- patients with chronic infection,e.g.tuberculosis,hepatitis or HIV infection,etc.
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to evaluate the status and function of gamma delta T cells in peripheral blood of sepsis patients.
Read the detailed description
Sepsis therapy is a prominent problem of the modern critical care medicine,and improving the level of sepsis treatment by immune intervention measures is a hot research topic with close attention.Gamma delta T cells is considered as one new T lymphocyte subset in recent years,which playing an important role in resistance to infection,anti-tumor and immune regulating function in the body.First,we played attention to the status and function of gamma delta T cells in peripheral blood of sepsis patients including differentiation marker,subtype and production of related cytokine,and then the molecular mechanism of insufficient gamma delta T cells.At the same time the responsibility of gamma delta T cells of sepsis patients to certain bacteria and viral antigen and the regulation of gamma delta T cells on other natural immune cells including NK cells and mononuclear cells were studied to identify the status and role gamma delta T cells in sepsis immunosuppression by culture in vitro.Further we studied the effect of specific stimulants on proliferation and activation of gamma delta T cells in patients with sepsis and also anti-infection acquired by gamma delta T cells,expecting as an entry point to explore new treatment strategy to sepsis.
- Conditions
- Sepsis
- Keywords
- sepsis, gamma delta T cells, immunosuppression
- Medical subject headings
- Sepsis
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 |
|---|---|---|
| severe sepsis and septic shock | patients were diagnosed severe sepsis or septic shock | |
| patient control | Patients after elective surgeries presented with SIRS but without sepsis | |
| volunteer | Health persons |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of activated gamma delta T cells
Measured: within 24h after recruitment
Secondary outcomes (1)
The percentage of apoptotic gamma delta T cells
Measured: within 24h after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2015 (estimated)
- Study startMay 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by West China 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kang Yan, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361970
- Sponsor's protocol ID
- Sepsis-kyan0127
- Status last verified
- May 2017
- First submitted
- 27 Jan 2015
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Role of Gamma Delta T Cells in Sepsis Immunosuppression and Its Molecular Mechanism
- ClinicalTrials.gov ID
- NCT02361970
- Acronym / sponsor ID
- Sepsis-kyan0127
- Conditions
- Sepsis
- Keywords
- sepsis, gamma delta T cells, immunosuppression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 12 Feb 2015 (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.
The purpose of the study is to evaluate the status and function of gamma delta T cells in peripheral blood of sepsis patients.
Detailed description
Sepsis therapy is a prominent problem of the modern critical care medicine,and improving the level of sepsis treatment by immune intervention measures is a hot research topic with close attention.Gamma delta T cells is considered as one new T lymphocyte subset in recent years,which playing an important role in resistance to infection,anti-tumor and immune regulating function in the body.First,we played attention to the status and function of gamma delta T cells in peripheral blood of sepsis patients including differentiation marker,subtype and production of related cytokine,and then the molecular mechanism of insufficient gamma delta T cells.At the same time the responsibility of gamma delta T cells of sepsis patients to certain bacteria and viral antigen and the regulation of gamma delta T cells on other natural immune cells including NK cells and mononuclear cells were studied to identify the status and role gamma delta T cells in sepsis immunosuppression by culture in vitro.Further we studied the effect of specific stimulants on proliferation and activation of gamma delta T cells in patients with sepsis and also anti-infection acquired by gamma delta T cells,expecting as an entry point to explore new treatment strategy to sepsis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| severe sepsis and septic shock | – | –patients were diagnosed severe sepsis or septic shock |
| patient control | – | –Patients after elective surgeries presented with SIRS but without sepsis |
| volunteer | – | –Health persons |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted in ICUs of West China Hospital
Key inclusion criteria (2 listed)
- clinical symptoms of severe sepsis and septic shock
- age over 18 years
Key exclusion criteria (4 listed)
- preexisting autoimmune disease
- patients received immuno-suppressive treatment in the previous 6 months
- patients with chronic infection,e.g.tuberculosis,hepatitis or HIV infection,etc.
- pregnancy
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
The percentage of activated gamma delta T cells
Time frame: within 24h after recruitment
1 secondary outcome
The percentage of apoptotic gamma delta T cells
Time frame: within 24h after recruitment
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 23 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sepsis, run by West China Hospital at 1 site in China.
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 2 inclusion and 4 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 23 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 China. 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?
The percentage of activated gamma delta T cells (time frame: within 24h after recruitment). 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 23 May 2017.