The Application of Soluble Triggering Receptor Expressed on Myeloid Cells-1 in Sepsis & Relevant Acute Kidney Injuries

Sepsis Clinical Trial

Official title:

A Prospective Study on the Diagnosis, Severity and Prognosis of Soluble Triggering Receptor Expressed on Myeloid Cells-1 in Sepsis & Related Complications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01333657
• Other study ID #: 301PLAGH-20090923-001
• Secondary ID: 2009BAI86B03
• Status: Completed
• Phase: N/A
• First received: April 7, 2011
• Last updated: August 2, 2011
• Start date: May 2010
• Est. completion date: April 2011

Study information

• Verified date: March 2011
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male and female aged 18 years old and over;

2. clinically suspected infection;

3. 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.

Exclusion Criteria:

Those who fulfilled one below:

• neutropenia (= 500 neutrophils/mm3)

• HIV infection, and

• patients or their relatives refused

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sepsis
• SIRS
• Toxemia

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No