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Urinary Proteomics Analysis for Sepsis and Prognosis

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:
NCT01493492
First received: December 14, 2011
Last updated: December 15, 2011
Last verified: December 2011

December 14, 2011
December 15, 2011
May 2010
January 2012   (final data collection date for primary outcome measure)
Survival status [ Time Frame: 28days after admited in 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
Complete list of historical versions of study NCT01493492 on ClinicalTrials.gov Archive Site
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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
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

    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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
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.
Both
18 Years and older
No
Contact: Longxiang Su, MD 15620952878 slx77@163.com
China
 
NCT01493492
20111013-007(1), 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