Urinary Proteomics Analysis for Sepsis and Prognosis

This study is currently recruiting participants.

Verified December 2011 by Chinese PLA General Hospital

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

History of Changes

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:

MedlinePlus related topics: Sepsis

U.S. FDA Resources

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 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

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

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):

Su L, Zhou R, Liu C, Wen B, Xiao K, Kong W, Tan F, Huang Y, Cao L, Xie L. Urinary proteomics analysis for sepsis biomarkers with iTRAQ labeling and two-dimensional liquid chromatography-tandem mass spectrometry. J Trauma Acute Care Surg. 2013 Mar;74(3):940-5. doi: 10.1097/TA.0b013e31828272c5.

Su L, Cao L, Zhou R, Jiang Z, Xiao K, Kong W, Wang H, Deng J, Wen B, Tan F, Zhang Y, Xie L. Identification of novel biomarkers for sepsis prognosis via urinary proteomic analysis using iTRAQ labeling and 2D-LC-MS/MS. PLoS One. 2013;8(1):e54237. doi: 10.1371/journal.pone.0054237. Epub 2013 Jan 23.

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

Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013

To Top