Comparison the Value of Several Biomarkers of Sepsis

Sepsis Clinical Trial

Official title:

Comparison of the Value of Serum sTREM-1, sCD163, PCT, CRP Concentrations, WBC Count and SOFA Score During Sepsis and Their Clinical Informative Value in Predicting Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01388725
• Other study ID #: 20090923-001,20100701-002
• Secondary ID: 2009BAI86B03
• Status: Completed
• Phase: N/A
• First received: July 5, 2011
• Last updated: July 6, 2011
• Start date: September 2009
• Est. completion date: July 2011

Study information

• Verified date: July 2010
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to describe the value of serum sTREM (soluble triggering receptor expressed on myeloid cells)-1, sCD163, procalcitonin (PCT), C-reactive protein (CRP) concentrations, white blood cell (WBC) count and SOFA score during sepsis and their clinical informative value in predicting outcome.

Description:

The investigators enrolled 130 subjects admitted to an ICU: 30 cases with systemic inflammatory response syndrome (SIRS), 36 cases with sepsis, 35 cases with and 29 with septic shock. Results for sTREM (soluble triggering receptor expressed on myeloid cells)-1, sCD163, procalcitonin (PCT), C-reactive protein (CRP) concentrations, white blood cell (WBC) count and SOFA score were recorded on days 1, 3, 5, 7, 10, and 14.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female aged 18 years old and over;

• Clinically suspected 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:

• Those who fulfilled one below:

• neutropenia (= 500 neutrophils/mm3)

• HIV infection, and

• patients or their relatives refused

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sepsis
• Systemic Inflammatory Response Syndrome
• Toxemia

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients Outcome	The survival time of patients more than 28 days is defined as survival. The survival time of patients less than 28 days is defined as death	28 days	No