MiRNAs Evaluate the Prognosis of Sepsis | NCT01207531

Studies
MiRNAs Evaluate the Prognosis of Sepsis

NCT01207531

Sponsor

Chinese PLA General Hospital

Status

Unknown status

Last Update Posted

Sep 23, 2010Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Sepsis

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Nov 2010Estimated

Completion Date

Apr 2011Estimated

First Submitted Date

Sep 17, 2010

First Submission Date that Met QC Criteria

Sep 22, 2010

First Posted Date

Sep 23, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2010

Last Update Posted Date

Sep 23, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Measure	Description	Time Frame
all cause mortality		28days after admited in ICU

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of sepsis
Patients who agree with the study

Exclusion Criteria:

Aged <18 years;
Into the group who died within 24 hours;
Agranulocytosis (<0.5 × 109 / L);
Combined HIV infection.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

within 24 hours after admited in ICU

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Huijuan Wang, master	Contact	+86 13466791738		wanghuijuan301@gmail.com

Overall Officials

Name	Affiliation	Role
Lixin Xie, Doctor	Pneumology Department of chinese PLA General Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chinese PLA General Hospital	Recruiting	Beijing	Beijing Municipality	100853	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22719975	Derived	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.

Label	Type	Description	Intervention Names
Survival Group
Death group

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes