Sepsis Clinical Trial
Official title:
Multi-marker Index for the Risk Assessment of Sepsis in the Emergency Department
The purpose of the study is to procure blood samples from patients ≥18 years of age who present to the Emergency Department (ED) with at least two of the diagnostic criteria for sepsis. Samples obtained upon enrollment will be used for future testing of the Triage Sepsis Panel and other biomarkers.
This is a multi-center, prospective specimen procurement study. The samples will be used for
future testing of the Triage Sepsis Panel in conjunction with other laboratory tests and
clinical assessments as an aid in the assessment for risk of sepsis progression within 72
hours of patients presenting in the Emergency Department and meeting the diagnostic criteria
for sepsis who might be considered for hospital admission, including to the ICU.
Approximately 700 patients presenting to the Emergency Department (ED) with at least two of
the symptoms or signs of sepsis will be enrolled in this study.
The day of enrollment is defined as Study Day 0. Enrolled patients who are discharged to
home will be contacted by telephone on Study Days 3, 14 and 28 to assess their clinical
status.
Patients who are admitted to the hospital following initial enrollment will undergo the
following assessments at 24, 48 and 72 hours after enrollment and at discharge (if in the
hospital and alive at these time points).
Each patient will also be contacted on Study Day 14 and on or after Study Day 28 to assess
the duration of hospital stay and mortality through Days 14 and 28.
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Time Perspective: Prospective
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