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

August 4, 2011 updated by: Chinese PLA General Hospital

The Value of Soluble TREM-1, Procalcitonin, and C-reactive Protein Serum Levels as Markers for the Detection of Sepsis and Bacteremia Among Patients With a Fever of Unknown Origin in Intensive Care Units

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

144

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Chinese PLA General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Between September 2009 and March 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
sepsis
SIRS + infection
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients Outcome
Time Frame: 28 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Investigators

  • Study Director: Xie Lixin, doctor, Department of Respiratory Diseases, Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

August 3, 2011

First Submitted That Met QC Criteria

August 4, 2011

First Posted (Estimate)

August 5, 2011

Study Record Updates

Last Update Posted (Estimate)

August 5, 2011

Last Update Submitted That Met QC Criteria

August 4, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20090923-001
  • 2009BAI86B03 (Other Grant/Funding Number: Chinese National Science & Technology Pillar Program)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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