SepsisNCT01504243
Association Between cd163 Gene Polymorphisms and Sepsis Among Chinese Han Population
An observational study of Sepsis, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
CD163 is a member of the scavenger receptor cysteine-rich family (SRCR) is exclusively expressed on cells of the monocyte lineage.CD163 acts to amplify inflammation and serves as a critical mediator of inflammatory response in the context of 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
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- May 2010to May 2012
- 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.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality
About this study
CD163 is a member of the scavenger receptor cysteine-rich family (SRCR) is exclusively expressed on cells of the monocyte lineage.CD163 acts to amplify inflammation and serves as a critical mediator of inflammatory response in the context of sepsis. This study was designed to investigate whether CD163 genomic variations were associated with the prognosis of sepsis. We sequenced 30 sepsis patients with CD163 gene of seventeen exons by PCR sequencing. When analyzing the results of sequencing, we found five gene polymorphisms located in exon-2,exon-5 and exon-11, respectively. Compare with the NCBI dbSNP and Hapmap database, one polymorphisms located in exon-2 is non-synonymous variation rs3210140, two polymorphisms located in exon-5 are synonymous variations rs4883264 and rs4883263, the last two located in exon-11 are synonymous variations rs61729512 and rs150018775 . Five common polymorphisms (rs2234237,rs2234246) within the CD163 gene were detected in 200 patients with severe sepsis and in 200 healthy control subjects. This study was explored that whether or not polymorphisms detected within the CD163 gene may play a major role in the predisposition to prognosis of sepsis in a Chinese Han cohort.
- Conditions
- Sepsis
- Keywords
- CD163;, 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 |
|---|---|---|
| Control | normal person under medical examination | |
| sepsis | SIRS plus inflammation |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2012 (estimated)
- Study startMay 2010
- Primary completionMay 2012 (estimated)
- Study completionMay 2012 (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 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Li xin Xie, MD, Study director, Respiratory Disease Department of chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01504243
- Sponsor's protocol ID
- 20111013-009（1）
- Other IDs
- 2009BAI86B03
- Status last verified
- Dec 2011
- First submitted
- 4 Jan 2012
- Last updated
- 5 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between cd163 Gene Polymorphisms and Sepsis Among Chinese Han Population
- ClinicalTrials.gov ID
- NCT01504243
- Acronym / sponsor ID
- 20111013-009（1）
- Conditions
- Sepsis
- Keywords
- CD163;, SNPs;, prognosis;, control（normal person）
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- May 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 5 Jan 2012 (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.
CD163 is a member of the scavenger receptor cysteine-rich family (SRCR) is exclusively expressed on cells of the monocyte lineage.CD163 acts to amplify inflammation and serves as a critical mediator of inflammatory response in the context of sepsis. This study was designed to investigate whether CD163 genomic variations were associated with the prognosis of sepsis. We sequenced 30 sepsis patients with CD163 gene of seventeen exons by PCR sequencing. When analyzing the results of sequencing, we found five gene polymorphisms located in exon-2,exon-5 and exon-11, respectively. Compare with the NCBI dbSNP and Hapmap database, one polymorphisms located in exon-2 is non-synonymous variation rs3210140, two polymorphisms located in exon-5 are synonymous variations rs4883264 and rs4883263, the last two located in exon-11 are synonymous variations rs61729512 and rs150018775 . Five common polymorphisms (rs2234237,rs2234246) within the CD163 gene were detected in 200 patients with severe sepsis and in 200 healthy control subjects. This study was explored that whether or not polymorphisms detected within the CD163 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 |
|---|---|---|
| Control | – | –normal person under medical examination |
| sepsis | – | –SIRS plus inflammation |
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2012.
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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.
Li xin 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: status not confirmed, as of the sponsor's last update on 5 Jan 2012. 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 Zhao xv Jiang, Ms (+86 15010540218, shanyuan1101@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 5 Jan 2012.