SepsisNCT02319876
Expression of TIM-3 on Lymphocytes in Sepsis
An observational study of Sepsis and Immunosuppression, run by Changhai Hospital at 1 site in China.
Trial summary
The current project was designed to examine the express TIM-3 on lymphocytes and monocytes and its role in immunosuppression during sepsis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Immunosuppression
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Feb 2014to Dec 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 ICU at Changhai Hospital
Who may be able to join
- patients with severe sepsis
- patients undergo invasive spine surgery
- healthy volunteers
Who cannot join
- patients with immunodeficient diseases
- patients who accept glucocorticoid or immunosuppressant
- patients with an age older than 18 years
- patients providing the informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Anesthesiology and Intensive Care, Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Lulong Bo, M.D., Ph.D., +13124781119, lulongbo@gmail.com
About this study
Official title: Expression and the Clinical Significance of TIM-3 on Lymphocytes During Sepsis
The current project was designed to examine the express TIM-3 on lymphocytes and monocytes and its role in immunosuppression during sepsis.
Read the detailed description
Immunosuppression is the leading cause of death in septic patients.Lymphocyte apoptosis has been recognized as an important step in the pathogenesis of sepsis. Previous studies indicated that T cell immunoglobulin and mucin protein 3 (TIM-3) is a type I cell surface protein and was identified as a marker of lymphocyte dysfunction. The current project was designed to examine the express TIM-3 on lymphocytes and monocytes and its further role in immunosuppression during sepsis.
- Conditions
- Sepsis, 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 | Patients with severe sepsis | |
| SIRS patient | Patients after elective surgeries presented with SIRS but without sepsis | |
| Volunteer | Volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
TIM-3 expression on CD4+, CD8+ T cells and CD14+ monocytes
TIM-3 level on T cells was compared between different populations.
Measured: within 24h after recruitment
Secondary outcomes (1)
28-day mortality
Measured: 28 days after diagnosis of sepsis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
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 Changhai 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoming Deng, Changhai Hospital
- Investigators
- Xiaoming Deng, M.D., Ph.D., Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319876
- Sponsor's protocol ID
- TIM3-SEPSIS
- Other IDs
- 81201492
- Status last verified
- Jun 2015
- First submitted
- 15 Dec 2014
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression and the Clinical Significance of TIM-3 on Lymphocytes During Sepsis
- ClinicalTrials.gov ID
- NCT02319876
- Acronym / sponsor ID
- TIM3-SEPSIS
- Conditions
- Sepsis, Immunosuppression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 18 Dec 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.
The current project was designed to examine the express TIM-3 on lymphocytes and monocytes and its role in immunosuppression during sepsis.
Detailed description
Immunosuppression is the leading cause of death in septic patients.Lymphocyte apoptosis has been recognized as an important step in the pathogenesis of sepsis. Previous studies indicated that T cell immunoglobulin and mucin protein 3 (TIM-3) is a type I cell surface protein and was identified as a marker of lymphocyte dysfunction. The current project was designed to examine the express TIM-3 on lymphocytes and monocytes and its further role in immunosuppression during sepsis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Severe sepsis | – | –Patients with severe sepsis |
| SIRS patient | – | –Patients after elective surgeries presented with SIRS but without sepsis |
| Volunteer | – | –Volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted in ICU at Changhai Hospital
Key inclusion criteria (3 listed)
- patients with severe sepsis
- patients undergo invasive spine surgery
- healthy volunteers
Key exclusion criteria (4 listed)
- patients with immunodeficient diseases
- patients who accept glucocorticoid or immunosuppressant
- patients with an age older than 18 years
- patients providing the informed consent
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
TIM-3 expression on CD4+, CD8+ T cells and CD14+ monocytes
Time frame: within 24h after recruitment
TIM-3 level on T cells was compared between different populations.
1 secondary outcome
28-day mortality
Time frame: 28 days after diagnosis of sepsis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
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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.
Xiaoming Deng, M.D., Ph.D. principal investigator
Changhai 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 Sepsis and Immunosuppression, run by Changhai 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 3 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: status not confirmed, as of the sponsor's last update on 29 Jul 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lulong Bo, M.D., Ph.D. (+862131163489, lulongbo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TIM-3 expression on CD4+, CD8+ T cells and CD14+ monocytes (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 29 Jul 2015; AzTrials last refreshed its copy on 6 Nov 2026.