Urinary Proteomics Analysis for Sepsis and Prognosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01493492
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 14, 2011
December 16, 2011
December 16, 2011
May 2010
January 2012   (Final data collection date for primary outcome measure)
Survival status [ Time Frame: 28days after admited in 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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Urinary Proteomics Analysis for Sepsis and Prognosis
Urinary Proteomics Analysis for Sepsis Identification and Its Prognosis in Sepsis Patient With iTRAQ Labeling and and LC-MS/MS
As a noninvasive examination, urinary proteomics is a very useful tool to identify renal disease. The purpose of the present study was to find differential proteins among patient with SIRS and sepsis(included survivors and non-survivors), and to screen potential biomarkers for the early diagnosis of sepsis and its prognosis. Urinary 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 Model: Case Control
Time Perspective: Prospective
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Probability Sample
All subjects were selected from among inpatients who were hospitalized between May 2010 and Jan 2012 in the Respiratory ICU, Surgical ICU, and Emergency ICU, Chinese People's Liberation Army (CPLA) General Hospital.
  • SIRS
  • Sepsis
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  • 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
  • sepsis


    1. sepsis: SIRS plus infection;
    2. severe sepsis: sepsis associated with organ dysfunction, hypoperfusion, or hypotension;
    3. septic shock: sepsis with arterial hypotension, despite adequate fluid resuscitation.
  • non-survivors with sepsis
    sepsis patients who died within 28 days

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
January 2012
January 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