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MiRNAs Evaluate the Prognosis of Sepsis by Dynamic Study (METPSDS)

This study is currently recruiting participants.
Verified August 2011 by Chinese PLA General Hospital
Sponsor:
Information provided by:
Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01459822
First received: October 24, 2011
Last updated: October 25, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition
Sepsis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: MiRNAhs in the Evaluation of the Value of Sepsis Prognosis Dynamics Observational Research

Resource links provided by NLM:

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Further study details as provided by Chinese PLA General Hospital:

Primary Outcome Measures:
  • all cause mortality [ Time Frame: 28days after admited in ICU ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

human serum


Estimated Enrollment: 70
Study Start Date: August 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Survival Group
Death Group

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

within 24 hours after admited in ICU

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01459822

Contacts
Contact: Jie Deng, master +86 18610095120 172534784@qq.com

Locations
China, Haidian
Chinese PLA General Hospital Recruiting
Beijing, Haidian, China, 100853
Contact: China            
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
Study Director: LiXin Xie, doctor Pneumology Department of chinese PLA General Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01459822     History of Changes
Other Study ID Numbers: 301PLAGH-20110824005
Study First Received: October 24, 2011
Last Updated: October 25, 2011
Health Authority: China: Ethics Committee

Keywords provided by Chinese PLA General Hospital:
sepsis
miRNA

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
 Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013