Circulating microRNAs as Biomarkers of Sepsis

May 2, 2013 updated by: Jia-feng Wang, Changhai Hospital

Diagnostic and Predictive Value of Circulating microRNAs During Sepsis

MicroRNA has been demonstrated to play a crucial role in regulating cell processes. Recently, microRNA was identified to exist in human serum or plasma, and it might be related to certain diseases. Several microRNAs are involved in sepsis, such as miR-146, miR-155, and so on. But whether serum miR-146 is present in serum of septic patients remains unknown. The present study was designed to identify the existence of specific microRNAs, which might be new markers for sepsis and its prognosis.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200433
        • Changhai Hospital, Second Military Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients who develop sepsis and SIRS

Description

Inclusion Criteria:

  • patients who develop sepsis and undergo abdominal surgery
  • patients who develop SIRS after cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

  • patients with a primary diagnosis of acute pancreatitis
  • patients with cirrhosis or renal dysfunction
  • patients with dyscrasia
  • patients with autoimmunity diseases
  • patients with severe cardiac and pulmonary diseases
  • patients with hematological diseases
  • patients who had organ dysfunction after cardiac surgery with cardiopulmonary bypass

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
sepsis group
Patients who develop sepsis in the ICU
SIRS group
Patients who develop SIRS after cardiac surgery with cardiopulmonary bypass
control group
normal healthy volunteers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relative amount of circulating microRNAs
Time Frame: On the second day of diagnosis of sepsis in ICU
On the second day of diagnosis of sepsis in ICU

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum levels of CRP and IL-6
Time Frame: On the second day of diagnosing sepsis
On the second day of diagnosing sepsis
Apache II score and death
Time Frame: On the second day of diagnosis of sepsis
On the second day of diagnosis of sepsis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Investigators

  • Principal Investigator: Ke-ming Zhu, M.D., Department of Anesthesiology and Intensive Care Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

March 13, 2009

First Submitted That Met QC Criteria

March 13, 2009

First Posted (Estimate)

March 16, 2009

Study Record Updates

Last Update Posted (Estimate)

May 3, 2013

Last Update Submitted That Met QC Criteria

May 2, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • microRNA_sepsis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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