Urinary Proteomics Analysis for Sepsis and Prognosis

NCT01493492 | Unknown DMC

• 2 other identifiers: 20111013-007(1)2009BAI86B03
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

SIRS; Sepsis

Keywords

proteomics,urinary,sepsis,prognosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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

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.

non-survivors with sepsis

sepsis patients who died within 28 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 23425763 DERIVED

• 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.

  PMID: 23372690 DERIVED

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lixin Xie, MD

  Department of Respiratory Diseases, Chinese PLA General Hospital

  STUDY DIRECTOR

Central Study Contacts

Longxiang Su, MD

CONTACT

15620952878; slx77@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 14, 2011
• First Posted: December 16, 2011
• Study Start: May 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: December 16, 2011

Record last verified: 2011-12

Locations

CN (1)