SepsisNCT01920217
Identification Sepsis Related Single Nucleotide Polymorphism (SNP) by Whole Exome Sequencing
An observational study of Sepsis, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Sepsis is a common cause of death in intensive care unit, timely and accurate diagnosis and treatment directly affect the survival rate. Single nucleotide polymorphism (SNP) was promising genetic biomarker for sepsis patients. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sepsis
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Dec 2015
- How long will I take part?
- 28 Days
- 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: within 24 hours after admited in ICU
Who may be able to join
- Clinical diagnosis of sepsis
- Patients who agree with the study
Who cannot join
- Aged <18 years;
- Into the group who died within 24 hours;
- Agranulocytosis (<0.5 × 109 / L);
- Combined HIV infection.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA general hospital
Beijing, Beijing Municipality, 100086
lixin xie, Dr, +86 1068185281, xielx@263.net
About this study
Official title: Identification Sepsis Related SNP by Whole Exome Sequencing: a Prospective Observational Study
Sepsis is a common cause of death in intensive care unit, timely and accurate diagnosis and treatment directly affect the survival rate. Single nucleotide polymorphism (SNP) was promising genetic biomarker for sepsis patients. The present study was designed to screen several SNP by whole exome sequencing which evaluate the sepsis related snp site in order to be a new target for the treatment of sepsis.
Read the detailed description
The study is a non-intervention, prospective observational study. Purpose of this sudy is to screening several SNPs by whole exome sequencing which can be used as genetic marker for sepsis patients. We will collect whole blood samples from patients with sepsis inRespiratory Intensive Care Unit (RICU), the Emergency Intensive Care Unit (EICU), or the Department of Surgery's ICU 301 Hospital since January 2013, and then whole exome sequencing was used to Screen SNPs which were related to sepsis. Then another 500 sepsis patients and 500 normal controls were used to validated the sequencing results.
- Conditions
- Sepsis
- Keywords
- sepsis, SNP, mortality
- 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 |
|---|---|---|
| normal control | Not described | |
| Sepsis group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
sepsis related SNP site
Measured: 28 days after admitted to ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startJan 2013
- Primary completionJan 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 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
- 1,000 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huijuan Wang, Chinese PLA General Hospital
- Investigators
- Huijuan Wang, Dr, Study director, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920217
- Sponsor's protocol ID
- 301PLAGH20130610
- Status last verified
- Aug 2013
- First submitted
- 8 Aug 2013
- Last updated
- 9 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification Sepsis Related SNP by Whole Exome Sequencing: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT01920217
- Acronym / sponsor ID
- 301PLAGH20130610
- Conditions
- Sepsis
- Keywords
- sepsis, SNP, mortality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 9 Aug 2013 (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.
Sepsis is a common cause of death in intensive care unit, timely and accurate diagnosis and treatment directly affect the survival rate. Single nucleotide polymorphism (SNP) was promising genetic biomarker for sepsis patients. The present study was designed to screen several SNP by whole exome sequencing which evaluate the sepsis related snp site in order to be a new target for the treatment of sepsis.
Detailed description
The study is a non-intervention, prospective observational study. Purpose of this sudy is to screening several SNPs by whole exome sequencing which can be used as genetic marker for sepsis patients. We will collect whole blood samples from patients with sepsis inRespiratory Intensive Care Unit (RICU), the Emergency Intensive Care Unit (EICU), or the Department of Surgery's ICU 301 Hospital since January 2013, and then whole exome sequencing was used to Screen SNPs which were related to sepsis. Then another 500 sepsis patients and 500 normal controls were used to validated the sequencing results.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal control | – | – |
| Sepsis group | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- within 24 hours after admited in ICU
Key inclusion criteria (2 listed)
- Clinical diagnosis of sepsis
- Patients who agree with the study
Key exclusion criteria (4 listed)
- Aged <18 years;
- Into the group who died within 24 hours;
- Agranulocytosis (<0.5 × 109 / L);
- Combined HIV infection.
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
sepsis related SNP site
Time frame: 28 days after admitted to ICU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2013.
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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.
Huijuan Wang, Dr study director
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 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: status not confirmed, as of the sponsor's last update on 9 Aug 2013. 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 Huijuan Wang, Dr (+86 13466791738, wanghuijuan301@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sepsis related SNP site (time frame: 28 days after admitted to ICU). 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 9 Aug 2013.