SepsisMETPSDSNCT01459822
MiRNAs Evaluate the Prognosis of Sepsis by Dynamic Study
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
- 70 participants
- Where
- 1 siteChina
- Study dates
- Aug 2011to Sep 2013
- 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, Haidian, 100853
China
About this study
Official title: MiRNAhs in the Evaluation of the Value of Sepsis Prognosis Dynamics Observational Research
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 observe the selected miRNA expression which evaluate the sepsis prognosis in the progression of sepsis in order to be a new target for the treatment of sepsis.
Read the detailed description
The study is a non-intervention observational study. Purpose of this study is to observe some selected miRNA expression which evaluate the sepsis prognosis in the progression of sepsis . The investigators will collect serum samples from patients with sepsis in SICU, RICU and EICU on the 1st、3rd、5th、7th、10th、14th day of 301 Hospital since November 2011 , and then use mirVana PARIS kit extract total RNA and use qRT-PCR detect miRNAS expression in serum 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 posted26 Oct 2011 (estimated)
- Study startAug 2011
- Primary completionJul 2013 (estimated)
- Study completionSep 2013 (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
- 70 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
- NCT01459822
- Sponsor's protocol ID
- 301PLAGH-20110824005
- Acronym
- METPSDS
- Status last verified
- Aug 2011
- First submitted
- 24 Oct 2011
- Last updated
- 26 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MiRNAhs in the Evaluation of the Value of Sepsis Prognosis Dynamics Observational Research
- ClinicalTrials.gov ID
- NCT01459822
- Acronym / sponsor ID
- METPSDS / 301PLAGH-20110824005
- Conditions
- Sepsis
- Keywords
- sepsis, miRNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 26 Oct 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.
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 observe the selected miRNA expression which evaluate the sepsis prognosis in the progression of sepsis in order to be a new target for the treatment of sepsis.
Detailed description
The study is a non-intervention observational study. Purpose of this study is to observe some selected miRNA expression which evaluate the sepsis prognosis in the progression of sepsis . The investigators will collect serum samples from patients with sepsis in SICU, RICU and EICU on the 1st、3rd、5th、7th、10th、14th day of 301 Hospital since November 2011 , and then use mirVana PARIS kit extract total RNA and use qRT-PCR detect miRNAS expression in serum 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 26 Oct 2011.
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Thymosin Alpha 1 and IgM Levels in Sepsis
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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, 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 26 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Deng, master (+86 18610095120, 172534784@qq.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?
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 26 Oct 2011.