NCT01333657

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 12, 2011

Completed
Last Updated

August 3, 2011

Status Verified

March 1, 2011

Enrollment Period

11 months

First QC Date

April 7, 2011

Last Update Submit

August 2, 2011

Conditions

Keywords

sTREM-1sepsisSIRSbloodurinediagnosisprognosis

Outcome Measures

Primary Outcomes (1)

  • 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.

    28 days

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Those who fulfilled one below:
  • neutropenia (≤ 500 neutrophils/mm3)
  • HIV infection, and
  • patients or their relatives refused

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

SepsisDisease

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Xie Lixin, Doctor

    Pneumology Department of chinese PLA General Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2011

First Posted

April 12, 2011

Study Start

May 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

August 3, 2011

Record last verified: 2011-03

Locations