Combined Determination of sTREM-1, PCT and CD64 in Diagnosing Sepsis

Combined Determination of sTREM-1, PCT and CD64 in Diagnosing Sepsis: a Prospective, Bicentric Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02198950

Enrollment

400

Registered

2014-07-24

Start date

2009-11-30

Completion date

2011-12-31

Last updated

2020-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critically Ill Patients

Keywords

sepsis, diagnosis, biomarker

Brief summary

The purpose of this study is to determine wether the combined measurement of the soluble form of TREM-1, PCT and the determination of neutrophils CD64 expression could diagnose sepsis in critically ill patients.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* all consecutive patients admitted into the ICU

Exclusion criteria

* absence of social protection

Design outcomes

Primary

Measure	Time frame	Description
Accuracy of sTREM-1, PCT, and CD64, taken alone or in combination in diagnosing sepsis in ICU patients as defined by the expert panel	28 days	A prospective study will be conducted in 300 patients admitted to a medical Intensive Care Unit, assaying serum concentrations of soluble Triggering Receptor Expressed on Myeloid cells-1 (sTREM-1) and procalcitonin (PCT), and measuring the expression of the high affinity immunoglobulin-Fc fragment receptor I (FcγRI) CD64 on neutrophils (PMN CD64 index) in flow cytometry. These biomarkers will be tested for their association with the diagnosis of infection. The final diagnosis of infection will be done by independent experts blinded for the results of CD64, sTREM-1, and PCT results. A Bioscore combining these biomarkers will be constructed and validated in an independent prospective cohort from another center.

Countries

France

Outcome results