Circulating microRNAs as Biomarkers of Sepsis | NCT00862290

Studies
Circulating microRNAs as Biomarkers of Sepsis

NCT00862290

Sponsor

Changhai Hospital

Status

Completed

Last Update Posted

May 3, 2013Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Sepsis

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Apr 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Mar 13, 2009

First Submission Date that Met QC Criteria

Mar 13, 2009

First Posted Date

Mar 16, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 2, 2013

Last Update Posted Date

May 3, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients who develop sepsis and SIRS

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ke-ming Zhu, M.D.	Department of Anesthesiology and Intensive Care Unit	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Changhai Hospital, Second Military Medical University		Shanghai		200433	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20188071	Result	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.

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes