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Urinary Proteomics Analysis for Sepsis and Prognosis

NCT ID: NCT01493492

Last Updated: 2011-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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SIRS Sepsis

Keywords

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proteomics,urinary,sepsis,prognosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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.

No interventions assigned to this group

non-survivors with sepsis

sepsis patients who died within 28 days

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Lixin Xie, MD

Role: STUDY_DIRECTOR

Department of Respiratory Diseases, Chinese PLA General Hospital

Locations

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Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Longxiang Su, MD

Role: CONTACT

Phone: 15620952878

Email: [email protected]

Facility Contacts

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Lixin Xie, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 23425763 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23372690 (View on PubMed)

Other Identifiers

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2009BAI86B03

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20111013-007(1)

Identifier Type: -

Identifier Source: org_study_id