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

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ClinicalTrials.gov Identifier: NCT02198950
Recruitment Status : Completed
First Posted : July 24, 2014
Last Update Posted : July 24, 2014
Sponsor:
Information provided by (Responsible Party):
Sebastien GIBOT, Central Hospital, Nancy, France

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.

Condition or disease
Critically Ill Patients

Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Combined Determination of sTREM-1, PCT and CD64 in Diagnosing Sepsis: a Prospective, Bicentric Study
Study Start Date : November 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Group/Cohort
ICU patients
all patients admitted into the ICU



Primary Outcome Measures :
  1. Accuracy of sTREM-1, PCT, and CD64, taken alone or in combination in diagnosing sepsis in ICU patients as defined by the expert panel [ Time Frame: 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.


Biospecimen Retention:   Samples Without DNA
plasmas


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patient admitted into the ICU
Criteria

Inclusion Criteria:

  • all consecutive patients admitted into the ICU

Exclusion Criteria:

  • absence of social protection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02198950


Locations
France
Bocage Hospital
Dijon, France
Central hospital
Nancy, France
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
Study Chair: Sebastien Gibot, MD, PhD Central Hospital, Nancy, France

Responsible Party: Sebastien GIBOT, Prof, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02198950     History of Changes
Other Study ID Numbers: 2009-A00870-57
First Posted: July 24, 2014    Key Record Dates
Last Update Posted: July 24, 2014
Last Verified: July 2014

Keywords provided by Sebastien GIBOT, Central Hospital, Nancy, France:
sepsis
diagnosis
biomarker

Additional relevant MeSH terms:
Sepsis
Critical Illness
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Disease Attributes