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Circulating microRNAs as Biomarkers of Sepsis

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ClinicalTrials.gov Identifier: NCT00862290
Recruitment Status : Completed
First Posted : March 16, 2009
Last Update Posted : May 3, 2013
Sponsor:
Information provided by (Responsible Party):
Jia-feng Wang, Changhai Hospital

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.

Condition or disease
Sepsis

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Diagnostic and Predictive Value of Circulating microRNAs During Sepsis
Study Start Date : August 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

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



Primary Outcome Measures :
  1. Relative amount of circulating microRNAs [ Time Frame: On the second day of diagnosis of sepsis in ICU ]

Secondary Outcome Measures :
  1. Serum levels of CRP and IL-6 [ Time Frame: On the second day of diagnosing sepsis ]
  2. Apache II score and death [ Time Frame: On the second day of diagnosis of sepsis ]

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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
patients who develop sepsis and SIRS
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00862290


Locations
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China
Changhai Hospital, Second Military Medical University
Shanghai, China, 200433
Sponsors and Collaborators
Changhai Hospital
Investigators
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Principal Investigator: Ke-ming Zhu, M.D. Department of Anesthesiology and Intensive Care Unit
Publications of Results:
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Responsible Party: Jia-feng Wang, M.D., Changhai Hospital
ClinicalTrials.gov Identifier: NCT00862290    
Other Study ID Numbers: microRNA_sepsis
First Posted: March 16, 2009    Key Record Dates
Last Update Posted: May 3, 2013
Last Verified: May 2013
Keywords provided by Jia-feng Wang, Changhai Hospital:
sepsis
microRNA
Additional relevant MeSH terms:
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Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes