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Serum Proteomics Analysis for Sepsis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Chinese PLA General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01493466
First received: December 15, 2011
Last updated: NA
Last verified: December 2011
History: No changes posted

December 15, 2011
December 15, 2011
May 2010
March 2012   (final data collection date for primary outcome measure)
Survival status [ Time Frame: 28 days after admission to ICU ] [ Designated as safety issue: No ]
The survival time of patients more than 28days is defined as survival. The survival time of patients less than 28days is defined as death.
Same as current
No Changes Posted
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Serum Proteomics Analysis for Sepsis
Serum Proteomics Analysis for Dynamic Changes of Differential Proteins in Sepsis Patient With iTRAQ Labeling and LC-MS/MS

Serum proteomics is a very useful tool to identify various disease. The purpose of the present study was to find differential proteins among patient with normal, SIRS, sepsis, severe sepsis, death and to screen potential biomarkers for their dynamic changes. Serum proteins were identified by iTRAQ labeling and LC-MS/MS. The bioinformatics analysis was performed with the Mascot software and the International Protein Index (IPI) and the Gene Ontology (GO) Database and KEGG pathway Database. The differentially expressed proteins were verified by Western blot by another sample collected from clinical.

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Observational
Time Perspective: Prospective
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Probability Sample

All subjects were selected from among inpatients who were hospitalized between May 2010 and Mar 2012 in the Respiratory ICU, Surgical ICU, and Emergency ICU, Chinese People's Liberation Army (CPLA) General Hospital.

  • SIRS
  • Sepsis
  • Severe Sepsis
  • Death
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  • Normal
    normal person under physical examination
  • SIRS
    1. temperature >38 ℃ or <36℃;
    2. pulse rate>90 beats/min;
    3. ventilatory rate>20 breaths/min or hyperventilation with partial pressure of arterial carbon dioxide (PaCO2)<32mmHg;
    4. white blood cell count>12,000μL-1 or <4000μL-1 or >10% immature cells
  • spesis
    sepsis is defined as SIRS plus confirmed infection.
  • severe sepsis
    1. severe sepsis: sepsis associated with organ dysfunction, hypoperfusion, or hypotension;
    2. septic shock: sepsis with arterial hypotension, despite adequate fluid resuscitation.
  • death
    sepsis patients within 48 hours before death
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
March 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female aged 18 years old and over;
  • clinically confirmed infection;
  • fulfilled at least two criteria of systemic inflammatory response syndrome
  • (a) core temperature higher than 38 °C or lower than 36 °C
  • (b)respiratory rate above 20/min, or PCO2 below 32 mmHg
  • (c) pulse rate above 90/min, and
  • (d) white blood cell count greater than 12,000/μl or lower than < 4,000/μl or less than 10% of bands.

Exclusion Criteria:

  • younger than 18 years of age;
  • acquired immunodeficiency syndrome;
  • reduced polymorphonuclear granulocyte counts (< 500 μL-1);
  • died within 24h after admission into the ICU, or refused to participate in the study, or declined treatment during the period of observation.
Both
18 Years and older
Yes
Contact: Longxiang Su, MD +86 15620952878 slx77@163.com
China
 
NCT01493466
20111013-007(2), 2009BAI86B03
Yes
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Chinese PLA General Hospital
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Study Director: Lixin Xie, MD Department of Respiratory Diseases, Chinese PLA General Hospital
Chinese PLA General Hospital
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP