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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| Measure | Description | Time Frame |
|---|---|---|
| Sepsis (according to the Third International Consensus Definitions (Sepsis-3 criteria)) within 3 days after inclusion. | Within 3 days after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| In-hospital mortality up to 30 days | Within 30 days after inclusion | |
| In-hospital mortality up to 7 days | Within 7 days after inclusion | |
| Sequential Organ Failure Assessment (SOFA) score |
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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:
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Adult patients who are admitted or are intended to be admitted to the hospital from the emergency department with suspected infection.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Affairs | Contact | 844-327-7078 | clinical@bluejaydx.com |
| Name | Affiliation | Role |
|---|---|---|
| Shapiro | Beth Israel Deaconess Medical Center | Principal Investigator |
| Peltan | Intermountain Health | Principal Investigator |
| Marchick |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida College of Medicine | Recruiting | Gainesville | Florida | 32610 | United States |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D012769 | Shock |
| D010335 | Pathologic Processes |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
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SOFA score has a range of 1 to 24, where higher scores represent higher degrees of single or multiple organ failure(s) |
| Within 3 days after inclusion |
| Hospital Length of Stay | Participants will be followed up for hospital length of stay for up to 30 days |
| ICU length of stay | Within 30 days after inclusion |
| Bacterial vs viral infection (As assessed by cultures and/or viral testing) | As assessed by cultures and/or viral testing. | Within 30 days after inclusion |
| Progression to septic shock | Participants will be followed up for progression to septic shock for up to 30 days | Within 30 days after inclusion |
| 30-day all-cause mortality in patients with a final diagnosis of sepsis or septic shock | Participants will be followed up for 30 days for all-cause mortality | Within 30 days after inclusion |
| Initiation of vasopressor therapy (by hospital discharge or up to 30 days) | within 30 days after inclusion |
| Initiation of renal replacement therapy (by hospital discharge or up to 30 days) | Within 30 days after inclusion |
| Initiation of mechanical ventilation (by hospital discharge or up to 30 days) | Within 30 days after inclusion |
| Free days from vasopressor therapy (by hospital discharge or up to 30 days) | Within 30 days after inclusion |
| Free days from renal replacement therapy (by hospital discharge or up to 30 days) | Within 30 days after inclusion |
| Free days from mechanical ventilation (by hospital discharge or up to 30 days) | Within 30 days after inclusion |
| Free days from vasopressor therapy, renal replacement therapy, or mechanical ventilation, (by hospital discharge or up to 30 days) | Within 30 days after inclusion |
| University of Florida |
| Principal Investigator |
| Ware | Vanderbilt University Medical Center | Principal Investigator |
| Mahler | Wake Forest University Health Sciences | Principal Investigator |
| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
|
| Wake Forest School of Medicine | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
|
| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37232 | United States |
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| Intermountain Health | Recruiting | Salt Lake City | Utah | 84111 | United States |
|