Comparison the Value of Several Biomarkers of Sepsis

This study has been completed.
Sponsor:
Information provided by:
Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01388725
First received: July 5, 2011
Last updated: July 6, 2011
Last verified: July 2010
  Purpose

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.


Condition
Systemic Inflammatory Response Syndrome
Sepsis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Chinese PLA General Hospital:

Primary Outcome Measures:
  • Patients Outcome [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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


Enrollment: 130
Study Start Date: September 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
SIRS
(1) temperature > 38oC or < 36oC; (2) pulse rate > 90 beats/min; (3) ventilation rate > 20 breaths/min or hyperventilation with a partial pressure of arterial carbon dioxide (PaCO2) < 32 mmHg; (4) white blood cell (WBC) count >1 2,000μL-1 or < 4000 μL-1 , or > 10% immature cells.
Sepsis
SIRS + infection

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Between September 2009 and July 2011, inpatients were included who were in the intensive care units (ICU) of the Department of Respiratory Disease, the Emergency Department, and the Department of Surgery of the Chinese People's Liberation Army General Hospital.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01388725

Locations
China, Beijing
Chinese PLA General Hospital
Beijing, Beijing, China, 100853
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
Study Director: Xie Lixin, Doctor Department Of Respiratory Diseases, Chinese PLA General Hospital
  More Information

No publications provided

Responsible Party: Lixin Xie, Department Of Respiratory Diseases, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01388725     History of Changes
Other Study ID Numbers: 20090923-001,20100701-002, 2009BAI86B03
Study First Received: July 5, 2011
Last Updated: July 6, 2011
Health Authority: China: Ethics Committee

Keywords provided by Chinese PLA General Hospital:
sTREM-1
sCD163
PCT
CRP
WBC count
SOFA score
SIRS
sepsis
severity
prognosis

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

ClinicalTrials.gov processed this record on July 28, 2014