Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bluejay Diagnostics, Inc.
Age
22–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adult patients (≥22 years of age)
Intent to admit to hospital or admitted to the hospital via the emergency department
At least 0.6 mL plasma drawn (optimal 1 mL) and available for collection (or is anticipated to be able to be drawn and available) within 12 hours of (i.e., up to 12 hours after) presentation to the emergency department. For Cohort 1, Criterion #1 criteria should be met within 3 hours of sample collection (fresh or remnant).
Meets criteria for at least one of the 3 cohorts (patients may be included in more than one cohort) within 12 hours of emergency department presentation:
1\. Cohort 1 (Systemic inflammatory response or culture ordered):
Criterion #1 (2 of below within 3 hours of sample collection, of which 1 is at least (A) or (B))
A) body temperature \>38C or \<36C,
B) HR\>90 beats/min,
C) respiratory rate \>20 breaths/min, or
D) white blood cell count \> 12K or \<4K/microliters or over 10% immature forms or bands) OR:
Criterion #2 (order for culture of a body fluid (e.g., blood, urine, sputum))
2\. Cohort 2 (Treatment for suspected infection initiated):
Meets criteria for Cohort 1 and antimicrobials (antibiotics or antivirals) ordered.
3\. Cohort 3 (Confirmed or strong evidence of infection):
Meets criteria for Cohorts 1 and 2, AND 1 or more of the following criteria:
Temp \>101F (38.3C)
pneumonia by x-ray or CT,
Urinalysis with WBC\>10/HPF;
Intraabdominal-pelvis infection by CT, U/S, or MRI
Skin / soft tissue infection by clinical exam
Evidence of meningitis on LP;
Positive microbiological culture (cultures drawn within 3 days of presentation)
Suspected line infection (e.g. redness or pus around the line)
You may not be if
Prisoners or imprisonment at time of enrollment
Pregnant
Prior enrollment into this study
Informed consent as approved by IRB is unable to be obtained.
Environmental exposure (e.g., heat exposure)
Clareo Health | Multicenter Symphony™ IL-6 Monitoring Sepsis ED Pilot Study
