SIRSNCT01333657
The Application of Soluble Triggering Receptor Expressed on Myeloid Cells-1 in Sepsis & Relevant Acute Kidney Injuries
An observational study of SIRS and Sepsis, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Triggering receptor expressed on myeloid cells-1 is a member of the immunoglobulin superfamily of receptors that is specifically expressed on the surfaces of monocytes and neutrophils.TREM-1 expression is increased in infectious diseases and is associated with the release of soluble TREM-1 (sTREM-1).There has been… Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- May 2010to Apr 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 May 2010 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.
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: A Prospective Study on the Diagnosis, Severity and Prognosis of Soluble Triggering Receptor Expressed on Myeloid Cells-1 in Sepsis & Related Complications
Triggering receptor expressed on myeloid cells-1 is a member of the immunoglobulin superfamily of receptors that is specifically expressed on the surfaces of monocytes and neutrophils.TREM-1 expression is increased in infectious diseases and is associated with the release of soluble TREM-1 (sTREM-1).There has been demonstrated that the value of plasma sTREM-1 levels as an indicator of sepsis was superior, although other studies reported that the value of sTREM-1 for diagnosing sepsis was inferior.An increasing number of studies indicate that there are increased levels of sTREM-1 in body fluid samples for the following diseases and conditions: sepsis, pneumonia, pleural effusion, septic arthritis, meningitis, peritonitis, and uterine cavity infection.
Inflammation is now believed to play a major role in the pathophysiology of AKI. It is hypothesized that the initial insult results in morphological and/or functional changes in vascular endothelial cells and/or in tubular epithelium in sepsis models. Then, leukocytes including neutrophils, macrophages, natural killer cells, and lymphocytes infiltrate into the injured kidneys and induce the generation of inflammatory mediators. Whether urine sTREM-1 could also be detected and its significance in sepsis and AKI has not been reported yet.
The present study focused on the value of serum \& urine sTREM-1 for sepsis identification, severity and prognosis assessments, and potential sepsis-related AKI. We also made comparisons between sTREM-1 and WBC counts, serum CRP, serum PCT, urine output,CC SCr, and BUN among sepsis patients.
- Keywords
- sTREM-1, sepsis, SIRS, blood, urine, diagnosis, prognosis
- Medical subject headings
- Sepsis, 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 |
|---|---|---|
| SIRS | 1. temperature >38 ℃ or <36℃; 2. pulse rate>90 beats/min; 3. ventilatory rate>20 breaths/min or hyperventilation with partial pressure of arterial carbon dioxide (PaCO2)<32mmHg; 4. white blood cell count>12,000μL-1 or <4000μL-1 or >10% immature cells | |
| Sepsis | 1. sepsis: SIRS plus infection; 2. severe sepsis: sepsis associated with organ dysfunction, hypoperfusion, or hypotension; 3. septic shock: sepsis with arterial hypotension, despite adequate fluid resuscitation. |
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 28days is defined as survival. The survival time of patients less than 28days 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 posted12 Apr 2011 (estimated)
- Study startMay 2010
- Primary completionApr 2011
- Study completionApr 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 only
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Xie Lixin, Doctor, Study director, Pneumology Department of chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333657
- Sponsor's protocol ID
- 301PLAGH-20090923-001
- Other IDs
- 2009BAI86B03
- Status last verified
- Mar 2011
- First submitted
- 7 Apr 2011
- Last updated
- 3 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Su LX, Feng L, Zhang J, Xiao YJ, Jia YH, Yan P, Feng D, Xie LX. Diagnostic value of urine sTREM-1 for sepsis and relevant acute kidney injuries: a prospective study. Crit Care. 2011;15(5):R250. doi: 10.1186/cc10508. Epub 2011 Oct 24.
PubMed 22023777
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Diagnosis, Severity and Prognosis of Soluble Triggering Receptor Expressed on Myeloid Cells-1 in Sepsis & Related Complications
- ClinicalTrials.gov ID
- NCT01333657
- Acronym / sponsor ID
- 301PLAGH-20090923-001
- Keywords
- sTREM-1, sepsis, SIRS, blood, urine, diagnosis, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 12 Apr 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.
Triggering receptor expressed on myeloid cells-1 is a member of the immunoglobulin superfamily of receptors that is specifically expressed on the surfaces of monocytes and neutrophils.TREM-1 expression is increased in infectious diseases and is associated with the release of soluble TREM-1 (sTREM-1).There has been demonstrated that the value of plasma sTREM-1 levels as an indicator of sepsis was superior, although other studies reported that the value of sTREM-1 for diagnosing sepsis was inferior.An increasing number of studies indicate that there are increased levels of sTREM-1 in body fluid samples for the following diseases and conditions: sepsis, pneumonia, pleural effusion, septic arthritis, meningitis, peritonitis, and uterine cavity infection.
Inflammation is now believed to play a major role in the pathophysiology of AKI. It is hypothesized that the initial insult results in morphological and/or functional changes in vascular endothelial cells and/or in tubular epithelium in sepsis models. Then, leukocytes including neutrophils, macrophages, natural killer cells, and lymphocytes infiltrate into the injured kidneys and induce the generation of inflammatory mediators. Whether urine sTREM-1 could also be detected and its significance in sepsis and AKI has not been reported yet.
The present study focused on the value of serum \& urine sTREM-1 for sepsis identification, severity and prognosis assessments, and potential sepsis-related AKI. We also made comparisons between sTREM-1 and WBC counts, serum CRP, serum PCT, urine output,CC SCr, and BUN among sepsis patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIRS | – | –1. temperature >38 ℃ or <36℃; 2. pulse rate>90 beats/min; 3. ventilatory rate>20 breaths/min or hyperventilation with partial pressure of arterial carbon dioxide (PaCO2)<32mmHg; 4. white blood cell count>12,000μL-1 or <4000μL-1 or >10% immature cells |
| Sepsis | – | –1. sepsis: SIRS plus infection; 2. severe sepsis: sepsis associated with organ dysfunction, hypoperfusion, or hypotension; 3. septic shock: sepsis with arterial hypotension, despite adequate fluid resuscitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Between May 2010 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 (3 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.
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 28days is defined as survival. The survival time of patients less than 28days 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 3 Aug 2011.
- Derived from this study: PubMed 22023777Su LX, Feng L, Zhang J, Xiao YJ, Jia YH, Yan P, Feng D, Xie LX. Diagnostic value of urine sTREM-1 for sepsis and relevant acute kidney injuries: a prospective study. Crit Care. 2011;15(5):R250. doi: 10.1186/cc10508. Epub 2011 Oct 24.
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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
Pneumology Department of 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 3 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 3 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 NCT01333657, 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 3 Aug 2011.