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Purpose

The primary objective of this study is to establish an IL-6 concentration cutoff that predicts sepsis or septic shock (according to the Third International Consensus Definitions (Sepsis-3 criteria)) in patients who are admitted or are intended to be admitted to the hospital from the emergency department with suspected infection.

Condition

Eligibility

Eligible Ages
Over 22 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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)

Exclusion Criteria

  • 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)

Study Design

Phase
Study Type
Observational
Observational Model
Case-Control
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Cohort 1: Systemic inflammatory response or culture ordered Criterion #1: (2 of the following within 3 hours of sample collection, of which 1 is at least (A or B): A) body temp >38c or <36c B) HR >90bpm C) respiratory rate >20 breaths/min 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 (blood, urine, sputum)
Cohort 2: Treatment for suspected infection initiated Meets criteria for Cohort 1 and antimicrobials (antibiotics or antivirals) ordered
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)

Recruiting Locations

University of Florida College of Medicine
Gainesville, Florida 32610
Contact:
Office of Research, MD
(352) 273-5946
COM-Research@ufl.edu

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Contact:
Clinical Trials Office
617-667-4443
cto@bidmc.harvard.edu

Wake Forest School of Medicine
Winston-Salem, North Carolina 27157
Contact:
Clinical Translation Science Institute
336-716-1195
ctsi@wakehealth.edu

Vanderbilt University Medical Center
Nashville, Tennessee 37232
Contact:
VUMC Office of Research
6153225000
sponsoredprograms@vumc.org

Intermountain Health
Salt Lake City, Utah 84111
Contact:
Clinical Trials Office
(801) 507-3950
intermountainresearch@imail.org

More Details

Status
Recruiting
Sponsor
Bluejay Diagnostics, Inc.

Study Contact

Clinical Affairs
844-327-7078
clinical@bluejaydx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.