Recruiting NCT07425587
Multicenter Symphony™ IL-6 Monitoring Sepsis ED Pilot Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Sepsis, Septic Shock. Basic parameters: from 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Sepsis (according to the Third International Consensus Definitions (Sepsis-3 criteria)) within 3 days after inclusion. [Time frame: Within 3 days after inclusion]
Secondary outcome measures (12)
- In-hospital mortality up to 30 days [Time frame: Within 30 days after inclusion]
- In-hospital mortality up to 7 days [Time frame: Within 7 days after inclusion]
- Sequential Organ Failure Assessment (SOFA) score [Time frame: Within 3 days after inclusion]
- Hospital Length of Stay [Time frame: Participants will be followed up for hospital length of stay for up to 30 days]
- ICU length of stay [Time frame: Within 30 days after inclusion]
- Bacterial vs viral infection (As assessed by cultures and/or viral testing) [Time frame: Within 30 days after inclusion]
- Progression to septic shock [Time frame: Within 30 days after inclusion]
- 30-day all-cause mortality in patients with a final diagnosis of sepsis or septic shock [Time frame: Within 30 days after inclusion]
- Initiation of vasopressor therapy (by hospital discharge or up to 30 days) [Time frame: within 30 days after inclusion]
- Initiation of renal replacement therapy (by hospital discharge or up to 30 days) [Time frame: Within 30 days after inclusion]
- Initiation of mechanical ventilation (by hospital discharge or up to 30 days) [Time frame: Within 30 days after inclusion]
- Free days from vasopressor therapy (by hospital discharge or up to 30 days) [Time frame: Within 30 days after inclusion]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United States · 5 centers
- University of Florida College of Medicine — Gainesville
- Beth Israel Deaconess Medical Center — Boston
- Wake Forest School of Medicine — Winston-Salem
- Vanderbilt University Medical Center — Nashville
- Intermountain Health — Salt Lake City
Identifiers
NCT: NCT07425587 · CES-0009