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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


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
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