Sepsis, Septic Shock
Conditions
Keywords
Interleukin-6, IL-6, Risk Stratification, Infections, Toxima, Systemic Inflammatory Response Syndrome, Inflammation, Sepsis, Septic Shock, Shock, Pathologic Process, Emergency Department
Brief summary
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.
Interventions
None listed
Sponsors
Bluejay Diagnostics, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sepsis (according to the Third International Consensus Definitions (Sepsis-3 criteria)) within 3 days after inclusion. | Within 3 days after inclusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
| Initiation of vasopressor therapy (by hospital discharge or up to 30 days) | within 30 days after inclusion | — |
| 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 | Within 3 days after inclusion | SOFA score has a range of 1 to 24, where higher scores represent higher degrees of single or multiple organ failure(s) |
| 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) | Within 30 days after inclusion | As assessed by cultures and/or viral testing. |
| Progression to septic shock | Within 30 days after inclusion | Participants will be followed up for progression to septic shock for up to 30 days |
| Free days from renal replacement therapy (by hospital discharge or 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 | Within 30 days after inclusion | Participants will be followed up for 30 days for all-cause mortality |
Countries
United States
Contacts
CONTACTClinical Affairs
PRINCIPAL_INVESTIGATORShapiro
Beth Israel Deaconess Medical Center
PRINCIPAL_INVESTIGATORPeltan
Intermountain Health
PRINCIPAL_INVESTIGATORMarchick
University of Florida
PRINCIPAL_INVESTIGATORWare
Vanderbilt University Medical Center
PRINCIPAL_INVESTIGATORMahler
Wake Forest University Health Sciences
Outcome results
None listed