- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01493492
Urinary Proteomics Analysis for Sepsis and Prognosis
December 15, 2011 updated by: Chinese PLA General Hospital
Urinary Proteomics Analysis for Sepsis Identification and Its Prognosis in Sepsis Patient With iTRAQ Labeling and and LC-MS/MS
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.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing
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Beijing, Beijing, China, 100853
- Recruiting
- Chinese PLA General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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SIRS
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sepsis
Sepsis
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non-survivors with sepsis
sepsis patients who died within 28 days
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival status
Time Frame: 28days after admited in ICU
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The survival time of patients more than 28days is defined as survival.
The survival time of patients less than 28days is defined as death
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28days after admited in ICU
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (ANTICIPATED)
January 1, 2012
Study Completion (ANTICIPATED)
January 1, 2012
Study Registration Dates
First Submitted
December 14, 2011
First Submitted That Met QC Criteria
December 15, 2011
First Posted (ESTIMATE)
December 16, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
December 16, 2011
Last Update Submitted That Met QC Criteria
December 15, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20111013-007(1)
- 2009BAI86B03 (Other Grant/Funding Number: Chinese National Science & Technology Pillar Program)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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