Serum Proteomics Analysis for Sepsis

NCT01493466 | Unknown DMC

• 2 other identifiers: 20111013-007(2)2009BAI86B03
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

SIRS; Sepsis; Severe Sepsis; Death

Keywords

proteomics,; serum,; sepsis,; potential biomarkers,; dynamic changes; normal

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.

  28 days after admission to ICU

Study Arms (5)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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 Mar 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

Beijin, Beijing Municipality, 100853, China

RECRUITING

Related Publications (1)

• Su L, Pan P, Yan P, Long Y, Zhou X, Wang X, Zhou R, Wen B, Xie L, Liu D. Role of vimentin in modulating immune cell apoptosis and inflammatory responses in sepsis. Sci Rep. 2019 Apr 5;9(1):5747. doi: 10.1038/s41598-019-42287-7.

  PMID: 30952998 DERIVED

MeSH Terms

Conditions

Sepsis; Death

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

+86 15620952878; slx77@163.com

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 15, 2011
• First Posted: December 16, 2011
• Study Start: May 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: December 16, 2011

Record last verified: 2011-12

Locations

CN (1)