Urinary Proteomics Analysis for Sepsis and Prognosis

Sponsor
Chinese PLA General Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01493492
Collaborator
(none)
60
1
20
3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Urinary Proteomics Analysis for Sepsis Identification and Its Prognosis in Sepsis Patient With iTRAQ Labeling and and LC-MS/MS
    Study Start Date :
    May 1, 2010
    Anticipated Primary Completion Date :
    Jan 1, 2012
    Anticipated Study Completion Date :
    Jan 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    SIRS

    temperature >38 ℃ or <36℃; pulse rate>90 beats/min; ventilatory rate>20 breaths/min or hyperventilation with partial pressure of arterial carbon dioxide (PaCO2)<32mmHg; white blood cell count>12,000μL-1 or <4000μL-1 or >10% immature cells

    sepsis

    Sepsis sepsis: SIRS plus infection; severe sepsis: sepsis associated with organ dysfunction, hypoperfusion, or hypotension; septic shock: sepsis with arterial hypotension, despite adequate fluid resuscitation.

    non-survivors with sepsis

    sepsis patients who died within 28 days

    Outcome Measures

    Primary Outcome Measures

    1. Survival status [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chinese PLA General Hospital Beijing Beijing China 100853

    Sponsors and Collaborators

    • Chinese PLA General Hospital

    Investigators

    • Study Director: Lixin Xie, MD, Department of Respiratory Diseases, Chinese PLA General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01493492
    Other Study ID Numbers:
    • 20111013-007(1)
    • 2009BAI86B03
    First Posted:
    Dec 16, 2011
    Last Update Posted:
    Dec 16, 2011
    Last Verified:
    Dec 1, 2011
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 16, 2011