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Serum Proteomics Analysis for Sepsis

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:
NCT01493466
First received: December 15, 2011
Last updated: NA
Last verified: December 2011
History: No changes posted
  Purpose

Serum proteomics is a very useful tool to identify various disease. The purpose of the present study was to find differential proteins among patient with normal, SIRS, sepsis, severe sepsis, death and to screen potential biomarkers for their dynamic changes. Serum 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
Severe Sepsis
Death

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Serum Proteomics Analysis for Dynamic Changes of Differential Proteins in Sepsis Patient With iTRAQ Labeling 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: 28 days after admission to 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: 100
Study Start Date: May 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal
normal person under physical examination
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
spesis
sepsis is defined as SIRS plus confirmed infection.
severe sepsis
  1. severe sepsis: sepsis associated with organ dysfunction, hypoperfusion, or hypotension;
  2. septic shock: sepsis with arterial hypotension, despite adequate fluid resuscitation.
death
sepsis patients within 48 hours before death

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

All subjects were selected from among inpatients who were hospitalized between May 2010 and Mar 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: NCT01493466

Contacts
Contact: Longxiang Su, MD +86 15620952878 slx77@163.com

Locations
China, Beijing
Chinese PLA General Hospital Recruiting
Beijin, 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

ClinicalTrials.gov Identifier: NCT01493466     History of Changes
Other Study ID Numbers: 20111013-007(2), 2009BAI86B03
Study First Received: December 15, 2011
Last Updated: December 15, 2011
Health Authority: China: Ethics Committee

Keywords provided by Chinese PLA General Hospital:
proteomics,
serum,
sepsis,
 potential biomarkers,
dynamic changes
normal

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
 Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013