SepsisNCT02180009
Dynamic Changes of Tim-3 on Monocytes and Soluble Tim-3 in Patients With Sepsis
An observational study of Sepsis and Severe Sepsis, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
In this study, the investigators will dynamically detect the expression of an immune regulator- T cell Ig and mucin domain protein 3 (Tim-3) in patient with sepsis. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Severe Sepsis, Septic Shock
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- Dec 2013to Dec 2015
- How long will I take part?
- 12 Months
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with sepsis
Who may be able to join
- More than one of the following:
- clinical manifestations: (1) a body temperature greater than 38℃ or less than 36℃; (2) a heart rate greater than 90 beats/minute; (3)tachypnea, manifested by a respiratory rate greater than 20 breaths per minute, or hyperventilation, as indicated by a PaCO2 of less than 32 mmHg; and (4)an alteration in the white blood cell count, such as a count greater than 12×10^9/L, a count less than 4×10^9/L, or the presence of more than 10 percent immature neutrophils
Who cannot join
- (1)patients younger than 18 years of age; (2)agranulocytosis (granulocyte counts,0.5×10^9/L); (3) those discharged within 24 h; (4) those diagnosed with HIV infection or cancer; and (5) patients who refused to participate.
Trial locations and contacts
1 site in 1 country.
About this study
In this study, the investigators will dynamically detect the expression of an immune regulator- T cell Ig and mucin domain protein 3 (Tim-3) in patient with sepsis.
Read the detailed description
In this study, we will collect the peripheral blood of 1,3,5,7,10,14 day after diagnose of sepsis.All the patients rolled in this study will be divided into three groups which is sepsis, severe sepsis and septic shock group according their severity. Then,the flow cytometry will be used to detect the express of Tim-3 on monocyte and ELISA will be used to exam the plasm soluble Tim-3.IL-6,IL-10,IL-12 and TNF-αin the peripheral blood will also be detected. We would like to find a new marker to predict the severity and prognosis of sepsis patients.
- Conditions
- Sepsis, Severe Sepsis, Septic Shock
- Medical subject headings
- Sepsis, Shock, Septic
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 |
|---|---|---|
| normal control | healthy people | |
| sepsis | mild response to infection | |
| severe sepsis | infection with at least one organ dysfunction | |
| septic shock | patients with septic shock |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startDec 2013
- Primary completionAug 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- 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
- 1 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Institute of Basic Medical Science
- Responsible party
- Principal investigator, Feifei Ren, Chinese PLA General Hospital
- Investigators
- Lixin Xie, PhD & MD, Principal investigator, Head of Department of Respiratory Medicine,Chinese PLA Gerneral Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180009
- Sponsor's protocol ID
- ZS2012009
- Status last verified
- Jan 2016
- First submitted
- 1 Jul 2014
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D, Cohen J, Opal SM, Vincent JL, Ramsay G; International Sepsis Definitions Conference. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Intensive Care Med. 2003 Apr;29(4):530-8. doi: 10.1007/s00134-003-1662-x. Epub 2003 Mar 28.
PubMed 12664219
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Changes of Tim-3 on Monocytes and Soluble Tim-3 in Patients With Sepsis
- ClinicalTrials.gov ID
- NCT02180009
- Acronym / sponsor ID
- ZS2012009
- Conditions
- Sepsis, Severe Sepsis, Septic Shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Beijing Institute of Basic Medical Science
- Study start
- Dec 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 2 Jul 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.
In this study, the investigators will dynamically detect the expression of an immune regulator- T cell Ig and mucin domain protein 3 (Tim-3) in patient with sepsis.
Detailed description
In this study, we will collect the peripheral blood of 1,3,5,7,10,14 day after diagnose of sepsis.All the patients rolled in this study will be divided into three groups which is sepsis, severe sepsis and septic shock group according their severity. Then,the flow cytometry will be used to detect the express of Tim-3 on monocyte and ELISA will be used to exam the plasm soluble Tim-3.IL-6,IL-10,IL-12 and TNF-αin the peripheral blood will also be detected. We would like to find a new marker to predict the severity and prognosis of sepsis patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| normal control | – | –healthy people |
| sepsis | – | –mild response to infection |
| severe sepsis | – | –infection with at least one organ dysfunction |
| septic shock | – | –patients with septic shock |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with sepsis
Key inclusion criteria (2 listed)
- More than one of the following:
- clinical manifestations: (1) a body temperature greater than 38℃ or less than 36℃; (2) a heart rate greater than 90 beats/minute; (3)tachypnea, manifested by a respiratory rate greater than 20 breaths per minute, or hyperventilation, as indicated by a PaCO2 of less than 32 mmHg; and (4)an alteration in the white blood cell count, such as a count greater than 12×10^9/L, a count less than 4×10^9/L, or the presence of more than 10 percent immature neutrophils
Key exclusion criteria (1 listed)
- (1)patients younger than 18 years of age; (2)agranulocytosis (granulocyte counts,0.5×10^9/L); (3) those discharged within 24 h; (4) those diagnosed with HIV infection or cancer; and (5) patients who refused to participate.
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
all cause mortality
Time frame: 28 days
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 28 Jan 2016.
- Background: PubMed 12664219Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D, Cohen J, Opal SM, Vincent JL, Ramsay G; International Sepsis Definitions Conference. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Intensive Care Med. 2003 Apr;29(4):530-8. doi: 10.1007/s00134-003-1662-x. Epub 2003 Mar 28.
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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.
Lixin Xie, PhD & MD principal investigator
Head of Department of Respiratory Medicine,Chinese PLA Gerneral 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 Severe Sepsis, run by Chinese PLA General 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 1 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 28 Jan 2016. 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?
all cause mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02180009, which also lists 1 linked publication.
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 28 Jan 2016.