MiRNAs Evaluate the Prognosis of Sepsis (METPS)
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | September 17, 2010 | ||||
| Last Updated Date | September 22, 2010 | ||||
| Start Date ICMJE | July 2010 | ||||
| Estimated Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
all cause mortality [ Time Frame: 28days after admited in ICU ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01207531 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | MiRNAs Evaluate the Prognosis of Sepsis | ||||
| Official Title ICMJE | miRNA in the Evaluation of the Value of Sepsis Prognosis Prospective Observational Study | ||||
| Brief 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. 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: human serum |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | within 24 hours after admited in ICU |
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| Condition ICMJE | Sepsis | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| 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. Epub 2012 Jun 15. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | April 2011 | ||||
| Estimated Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01207531 | ||||
| Other Study ID Numbers ICMJE | 301PLAGH-2010915 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Lixin Xie, Pneumology Department of Chinese PLA General Hospital | ||||
| Study Sponsor ICMJE | Chinese PLA General Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Chinese PLA General Hospital | ||||
| Verification Date | September 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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