Circulating microRNAs as Biomarkers of Sepsis

NCT00862290 | Completed DMC

• 1 other identifier: microRNA_sepsis
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sepsis

Keywords

sepsis; microRNA

Outcome Measures

Primary Outcomes (1)

• Relative amount of circulating microRNAs

  On the second day of diagnosis of sepsis in ICU

Secondary Outcomes (2)

• Serum levels of CRP and IL-6

  On the second day of diagnosing sepsis

• Apache II score and death

  On the second day of diagnosis of sepsis

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients who develop sepsis and SIRS

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital, Second Military Medical University

Shanghai, 200433, China

Location

Related Publications (1)

• Wang JF, Yu ML, Yu G, Bian JJ, Deng XM, Wan XJ, Zhu KM. Serum miR-146a and miR-223 as potential new biomarkers for sepsis. Biochem Biophys Res Commun. 2010 Mar 26;394(1):184-8. doi: 10.1016/j.bbrc.2010.02.145. Epub 2010 Feb 24.

  PMID: 20188071 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood of septic patients is collected on the second day when they are diagnosed with sepsis in ICU. Blood of SIRS patients is collected on the second day when they are diagnozed with SIRS after cardiac surgery with cardiopulmonary bypass.

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ke-ming Zhu, M.D.

  Department of Anesthesiology and Intensive Care Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: March 13, 2009
• First Posted: March 16, 2009
• Study Start: August 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: June 1, 2009
• Last Updated: May 3, 2013

Record last verified: 2013-05

Locations

CN (1)