NCT01207531

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 23, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

September 23, 2010

Status Verified

September 1, 2010

Enrollment Period

4 months

First QC Date

September 17, 2010

Last Update Submit

September 22, 2010

Conditions

Sepsis

Keywords

sepsismiRNA

Outcome Measures

Primary Outcomes (1)

  • all cause mortality

    28days after admited in ICU

Study Arms (2)

Survival Group

Death group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

within 24 hours after admited in ICU

You may qualify if:

  • Clinical diagnosis of sepsis
  • Patients who agree with the study

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 22719975DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

human serum

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lixin Xie, Doctor

    Pneumology Department of chinese PLA General Hospital

    STUDY DIRECTOR

Central Study Contacts

Huijuan Wang, master

CONTACT

+86 13466791738wanghuijuan301@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 17, 2010

First Posted

September 23, 2010

Study Start

July 1, 2010

Primary Completion

November 1, 2010

Study Completion

April 1, 2011

Last Updated

September 23, 2010

Record last verified: 2010-09

Locations

CN(1)