SepsisNCT01490424
TREM-1 Gene Polymorphisms
An observational study of Sepsis, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Triggering receptor expressed on myeloid cells-1 (TREM-1) is a cell surface receptor expressed on neutrophils and monocytes. TREM-1 acts to amplify inflammation and serves as a critical mediator of inflammatory response in the context of sepsis. Blocking of TREM-1 can protect against sepsis in mice. 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
- 160 participants
- Where
- 1 siteChina
- Study dates
- May 2010to Oct 2011
- 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: All subjects were selected from among inpatients who were hospitalized between September 2009 and October 2011 in the Respiratory ICU, Surgical ICU, and Emergency ICU, Chinese People's Liberation Army (CPLA) General Hospital.
Who may be able to join
- Sepsis met the criteria recommended by 1991 ACCP/SCCM Joint Meeting and by the diagnostic criteria developed at the 2001 International Sepsis Definition Conference.
Who cannot join
- (1) younger than 18 years of age; (2) acquired immunodeficiency syndrome; (3) reduced polymorphonuclear granulocyte counts (< 500 μL-1); (4) died within 24h after admission into the ICU, or refused to participate in the study, or declined treatment during the period of observation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between TREM-1 Gene Polymorphisms and Prognosis in Sepsis Patient
Triggering receptor expressed on myeloid cells-1 (TREM-1) is a cell surface receptor expressed on neutrophils and monocytes. TREM-1 acts to amplify inflammation and serves as a critical mediator of inflammatory response in the context of sepsis. Blocking of TREM-1 can protect against sepsis in mice. This study was designed to investigate whether TREM-1 genomic variations were associated with the prognosis of sepsis. We sequenced 30 sepsis patients with TREM-1 gene of four exons by PCR sequencing. When analyzing the results of sequencing, we found two gene polymorphisms located in exon-2 and exon-4, respectively. Compare with the NCBI dbSNP and Hapmap database, one polymorphisms located in exon-2 is non-synonymous variation rs2234237（Ser25Thr）, the other one located in exon-4 is synonymous variation rs2234246. Two common polymorphisms (rs2234237,rs2234246) within the TREM-1 gene were detected in 80 patients with severe sepsis and in 80 healthy control subjects. This study was explored that whether or not polymorphisms detected within the TREM-1 gene may play a major role in the predisposition to prognosis of sepsis in a Chinese Han cohort.
- Conditions
- Sepsis
- Keywords
- TREM-1;, SNPs;, prognosis, control（normal person）
- 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 |
|---|---|---|
| sepsis | SIRS plus inflammation | |
| Control | normal person under medical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients Outcome
The survival time of patients more than 28days is defined as survival. The survival time of patients less than 28days is defined as death
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 posted13 Dec 2011 (estimated)
- Study startMay 2010
- Primary completionOct 2011
- Study completionOct 2011
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.
- More trials run by Chinese PLA General 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Lixin Xie, MD, Study director, Respiratory Disease Department of chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01490424
- Sponsor's protocol ID
- 20111013-009（2）
- Other IDs
- 2009BAI86B03
- Status last verified
- Dec 2011
- First submitted
- 12 Dec 2011
- Last updated
- 13 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Su L, Liu C, Li C, Jiang Z, Xiao K, Zhang X, Li M, Yan P, Feng D, Xie L. Dynamic changes in serum soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) and its gene polymorphisms are associated with sepsis prognosis. Inflammation. 2012 Dec;35(6):1833-43. doi: 10.1007/s10753-012-9504-z.
PubMed 22798017
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between TREM-1 Gene Polymorphisms and Prognosis in Sepsis Patient
- ClinicalTrials.gov ID
- NCT01490424
- Acronym / sponsor ID
- 20111013-009（2）
- Conditions
- Sepsis
- Keywords
- TREM-1;, SNPs;, prognosis, control（normal person）
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 13 Dec 2011 (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.
Triggering receptor expressed on myeloid cells-1 (TREM-1) is a cell surface receptor expressed on neutrophils and monocytes. TREM-1 acts to amplify inflammation and serves as a critical mediator of inflammatory response in the context of sepsis. Blocking of TREM-1 can protect against sepsis in mice. This study was designed to investigate whether TREM-1 genomic variations were associated with the prognosis of sepsis. We sequenced 30 sepsis patients with TREM-1 gene of four exons by PCR sequencing. When analyzing the results of sequencing, we found two gene polymorphisms located in exon-2 and exon-4, respectively. Compare with the NCBI dbSNP and Hapmap database, one polymorphisms located in exon-2 is non-synonymous variation rs2234237（Ser25Thr）, the other one located in exon-4 is synonymous variation rs2234246. Two common polymorphisms (rs2234237,rs2234246) within the TREM-1 gene were detected in 80 patients with severe sepsis and in 80 healthy control subjects. This study was explored that whether or not polymorphisms detected within the TREM-1 gene may play a major role in the predisposition to prognosis of sepsis in a Chinese Han cohort.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sepsis | – | –SIRS plus inflammation |
| Control | – | –normal person under medical examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects were selected from among inpatients who were hospitalized between September 2009 and October 2011 in the Respiratory ICU, Surgical ICU, and Emergency ICU, Chinese People's Liberation Army (CPLA) General Hospital.
Key inclusion criteria (1 listed)
- Sepsis met the criteria recommended by 1991 ACCP/SCCM Joint Meeting and by the diagnostic criteria developed at the 2001 International Sepsis Definition Conference.
Key exclusion criteria (1 listed)
- (1) younger than 18 years of age; (2) acquired immunodeficiency syndrome; (3) reduced polymorphonuclear granulocyte counts (< 500 μL-1); (4) died within 24h after admission into the ICU, or refused to participate in the study, or declined treatment during the period of observation.
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
Patients Outcome
Time frame: 28 days
The survival time of patients more than 28days is defined as survival. The survival time of patients less than 28days is defined as death
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 13 Dec 2011.
- Derived from this study: PubMed 22798017Su L, Liu C, Li C, Jiang Z, Xiao K, Zhang X, Li M, Yan P, Feng D, Xie L. Dynamic changes in serum soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) and its gene polymorphisms are associated with sepsis prognosis. Inflammation. 2012 Dec;35(6):1833-43. doi: 10.1007/s10753-012-9504-z.
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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, MD study director
Respiratory Disease Department of chinese PLA General 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, 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 1 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 13 Dec 2011. 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?
Patients Outcome (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 NCT01490424, 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 13 Dec 2011; AzTrials last refreshed its copy on 1 Nov 2026.