Urinary Proteomics Analysis for Sepsis and Prognosis

Sepsis Clinical Trial

Official title:

Urinary Proteomics Analysis for Sepsis Identification and Its Prognosis in Sepsis Patient With iTRAQ Labeling and and LC-MS/MS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01493492
• Other study ID #: 20111013-007(1)
• Secondary ID: 2009BAI86B03
• Status: Recruiting
• Phase: N/A
• First received: December 14, 2011
• Last updated: December 15, 2011
• Start date: May 2010
• Est. completion date: January 2012

Study information

• Verified date: December 2011
• Source: Chinese PLA General Hospital
• Contact: Longxiang Su, MD
• Phone: 15620952878
• Email: slx77[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sepsis
• SIRS
• Toxemia

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival status	The survival time of patients more than 28days is defined as survival. The survival time of patients less than 28days is defined as death	28days after admited in ICU	No