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Serum Proteomics Analysis for Sepsis

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ClinicalTrials.gov Identifier: NCT01493466
Recruitment Status : Unknown
Verified December 2011 by Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : December 16, 2011
Last Update Posted : December 16, 2011
Information provided by:
Chinese PLA General Hospital

December 15, 2011
December 16, 2011
December 16, 2011
May 2010
March 2012   (Final data collection date for primary outcome measure)
Survival status [ Time Frame: 28 days after admission to ICU ]
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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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.
Unknown status
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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
2009BAI86B03 ( Other Grant/Funding Number: Chinese National Science & Technology Pillar Program )
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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