SepsisMETPSNCT01207531
MiRNAs Evaluate the Prognosis of Sepsis
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. MiRNA is a post-transcriptional small RNA which regulate mRNA expression. 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
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jul 2010to Apr 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: 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, 100853
About this study
Official title: miRNA in the Evaluation of the Value of Sepsis Prognosis 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. MiRNA is a post-transcriptional small RNA which regulate mRNA expression. The present study was designed to screen several miRNA by microarray which evaluate the sepsis prognosis 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 miRNAs by microarray which can evaluate the prognosis of sepsis . We will collect serum samples from patients with sepsis in SICU, RICU and EICU of 301 Hospital since September 2009 , and then use the chip and qRT-PCR to Screen miRNAs which can evaluate the prognosis of sepsis, and statistical analysis the miRNAS expression correlation with SOFA score.
- Conditions
- Sepsis
- Keywords
- sepsis, miRNA
- 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 |
|---|---|---|
| Survival Group | Not described | |
| Death group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: 28days after admited in ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2010 (estimated)
- Study startJul 2010
- Primary completionNov 2010 (estimated)
- Study completionApr 2011 (estimated)
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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Lixin Xie, Doctor, Study director, Pneumology Department of chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207531
- Sponsor's protocol ID
- 301PLAGH-2010915
- Acronym
- METPS
- Status last verified
- Sep 2010
- First submitted
- 17 Sep 2010
- Last updated
- 23 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang H, Zhang P, Chen W, Feng D, Jia Y, Xie L. Serum microRNA signatures identified by Solexa sequencing predict sepsis patients' mortality: a prospective observational study. PLoS One. 2012;7(6):e38885. doi: 10.1371/journal.pone.0038885. Epub 2012 Jun 15.
PubMed 22719975
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- miRNA in the Evaluation of the Value of Sepsis Prognosis Prospective Observational Study
- ClinicalTrials.gov ID
- NCT01207531
- Acronym / sponsor ID
- METPS / 301PLAGH-2010915
- Conditions
- Sepsis
- Keywords
- sepsis, miRNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 23 Sep 2010 (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. MiRNA is a post-transcriptional small RNA which regulate mRNA expression. The present study was designed to screen several miRNA by microarray which evaluate the sepsis prognosis 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 miRNAs by microarray which can evaluate the prognosis of sepsis . We will collect serum samples from patients with sepsis in SICU, RICU and EICU of 301 Hospital since September 2009 , and then use the chip and qRT-PCR to Screen miRNAs which can evaluate the prognosis of sepsis, and statistical analysis the miRNAS expression correlation with SOFA score.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survival Group | – | – |
| Death group | – | – |
Who may qualify
- Ages
- 18 years and older
- 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
all cause mortality
Time frame: 28days after admited in ICU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2010.
- Derived from this study: PubMed 22719975Wang H, Zhang P, Chen W, Feng D, Jia Y, Xie L. Serum microRNA signatures identified by Solexa sequencing predict sepsis patients' mortality: a prospective observational study. PLoS One. 2012;7(6):e38885. doi: 10.1371/journal.pone.0038885. Epub 2012 Jun 15.
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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, Doctor study director
Pneumology 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 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 23 Sep 2010. 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, master (+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?
all cause mortality (time frame: 28days after admited in ICU). 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 NCT01207531, 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 23 Sep 2010.