The Value of sTREM-1, PCT, and CRP as Markers for the Detection of Sepsis and Bacteremia Among Patients With a FUO

NCT ID: NCT01410578

Last Updated: 2011-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

144 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-03-31

Brief Summary

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The investigators enrolled 144 subjects admitted to ICUs: 60 patients with systemic inflammatory response syndrome (SIRS) and 84 patients with sepsis. Tests for serum sTREM-1, PCT, and CRP levels and blood culture were performed on the day of admission and with the occurrence of FUO (\>38.3ºC) during hospitalization. Based on the results of blood culture, the subjects were divided into bacteremia (33 patients) and non-bacteremia groups (51 patients). Based on 28-day survival, bacteremia patients were also divided into survivor (22 patients) and non-survivor groups (11 patients). Serum sTREM-1 and PCT levels were summarized as medians (interquartile ranges) and CRP levels were presented as means ± standard deviations. To explore the early diagnostic value of soluble triggering receptor expressed on myeloid cells 1 (sTREM-1), procalcitonin (PCT), and C-reactive protein (CRP) serum levels for identification of sepsis and bacteremia and the prognosis among patients with a fever of unknown origin (FUO) in the intensive care unit (ICU) and to discuss the clinical application of the results.

Detailed Description

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Conditions

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SIRS Sepsis Bacteremia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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systemic inflammatory response syndrome

(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.

No interventions assigned to this group

sepsis

SIRS + infection

No interventions assigned to this group

bacteremia

(1) The blood culture tested positive at least for the same pathogen;(2) The patient had at least one of the following symptoms: fever, shivering, or low blood pressure and showed signs of at least one of the following conditions: the blood culture tested positive at least twice for common skin flora from different sites; the blood culture tested positive only once for the skin flora listed above, the intravascular catheter culture tested positive for the same pathogen and the correct antibiotic treatment had been initiated for the patient; or a positive serology test consistent with other clinical laboratory test results and unrelated to infections at different sites.

No interventions assigned to this group

Eligibility Criteria

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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;
* Blood borne infections were diagnosed if the following criteria were met.(1) The blood culture tested positive at least for the same pathogen;(2) The patient had at least one of the following symptoms: fever, shivering, or low blood pressure and showed signs of at least one of the following conditions: the blood culture tested positive at least twice for common skin flora from different sites; the blood culture tested positive only once for the skin flora listed above, the intravascular catheter culture tested positive for the same pathogen and the correct antibiotic treatment had been initiated for the patient; or a positive serology test consistent with other clinical laboratory test results and unrelated to infections at different sites.

Exclusion Criteria

Those who fulfilled one below:

* neutropenia (≤ 500 neutrophils/mm3)
* HIV infection, and
* patients or their relatives refused
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Department Of Respiratory Diseases, Chinese PLA General Hospital

Principal Investigators

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Xie Lixin, doctor

Role: STUDY_DIRECTOR

Department Of Respiratory Diseases, Chinese PLA General Hospital

Locations

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Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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Su L, Han B, Liu C, Liang L, Jiang Z, Deng J, Yan P, Jia Y, Feng D, Xie L. Value of soluble TREM-1, procalcitonin, and C-reactive protein serum levels as biomarkers for detecting bacteremia among sepsis patients with new fever in intensive care units: a prospective cohort study. BMC Infect Dis. 2012 Jul 18;12:157. doi: 10.1186/1471-2334-12-157.

Reference Type DERIVED
PMID: 22809118 (View on PubMed)

Other Identifiers

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2009BAI86B03

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20090923-001

Identifier Type: -

Identifier Source: org_study_id

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