SIRSNCT01410578
The Value of sTREM-1, PCT, and CRP as Markers for the Detection of Sepsis and Bacteremia Among Patients With a FUO
An observational study of SIRS and Sepsis, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SIRS, Sepsis, Bacteremia
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- Sep 2009to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Those who fulfilled one below:
- neutropenia (≤ 500 neutrophils/mm3)
- HIV infection, and
- patients or their relatives refused
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- SIRS, Sepsis, Bacteremia
- Keywords
- sTRE-1, PCT, CRP, sepsis, bacteremia, FUO, diagnosis, prognosis
- Medical subject headings
- Sepsis, Bacteremia, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| sepsis | SIRS + infection | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2011 (estimated)
- Study startSep 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SIRSStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Xie Lixin, doctor, Study director, Department Of Respiratory Diseases, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410578
- Sponsor's protocol ID
- 20090923-001
- Other IDs
- 2009BAI86B03
- Status last verified
- Mar 2011
- First submitted
- 3 Aug 2011
- Last updated
- 5 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22809118
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01410578
- Acronym / sponsor ID
- 20090923-001
- Conditions
- SIRS, Sepsis, Bacteremia
- Keywords
- sTRE-1, PCT, CRP, sepsis, bacteremia, FUO, diagnosis, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 5 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
| sepsis | – | –SIRS + infection |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- neutropenia (≤ 500 neutrophils/mm3)
- HIV infection, and
- patients or their relatives refused
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2011.
- Derived from this study: PubMed 22809118Su 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xie Lixin, doctor study director
Department Of Respiratory Diseases, Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SIRS and Sepsis, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients Outcome (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01410578, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2011.