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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


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
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