Circulating microRNAs as Biomarkers of Sepsis

Sepsis Clinical Trial

Official title:

Diagnostic and Predictive Value of Circulating microRNAs During Sepsis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00862290
• Other study ID #: microRNA_sepsis
• Status: Completed
• Phase: N/A
• First received: March 13, 2009
• Last updated: May 2, 2013
• Start date: August 2008
• Est. completion date: June 2009

Study information

• Verified date: May 2013
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Locations

Country	Name	City	State
China	Changhai Hospital, Second Military Medical University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative amount of circulating microRNAs		On the second day of diagnosis of sepsis in ICU	Yes
Secondary	Serum levels of CRP and IL-6		On the second day of diagnosing sepsis	Yes
Secondary	Apache II score and death		On the second day of diagnosis of sepsis	Yes