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
  Purpose

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
SIRS
Sepsis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Chinese PLA General Hospital:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 60
Study Start Date: May 2010
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01493492

Contacts
Contact: Longxiang Su, MD 15620952878 slx77@163.com

Locations
China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Lixin Xie, MD       xielx@263.net   
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
Study Director: Lixin Xie, MD Department of Respiratory Diseases, Chinese PLA General Hospital
  More Information

No publications provided by Chinese PLA General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01493492     History of Changes
Other Study ID Numbers: 20111013-007(1), 2009BAI86B03
Study First Received: December 14, 2011
Last Updated: December 15, 2011
Health Authority: China: Ethics Committee

Keywords provided by Chinese PLA General Hospital:
proteomics,urinary,sepsis,prognosis

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Inflammation
Pathologic Processes
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on October 22, 2014