Critically Ill Patients Clinical Trial
Official title:
Combined Determination of sTREM-1, PCT and CD64 in Diagnosing Sepsis: a Prospective, Bicentric Study
NCT number | NCT02198950 |
Other study ID # | 2009-A00870-57 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 2009 |
Est. completion date | December 2011 |
Verified date | September 2020 |
Source | Central Hospital, Nancy, France |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 400 |
Est. completion date | December 2011 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - all consecutive patients admitted into the ICU Exclusion Criteria: - absence of social protection |
Country | Name | City | State |
---|---|---|---|
France | Bocage Hospital | Dijon | |
France | Central hospital | Nancy |
Lead Sponsor | Collaborator |
---|---|
Central Hospital, Nancy, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy of sTREM-1, PCT, and CD64, taken alone or in combination in diagnosing sepsis in ICU patients as defined by the expert panel | 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 (Fc?RI) 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. | 28 days |
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