Recruiting NCT06654895
Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation 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 →
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Overview
The primary objective of this study is to validate a pre-defined IL-6 concentration cutoff that predicts 28-day mortality in patients who are admitted or are intended to be admitted to the ICU diagnosed with sepsis or septic shock.
Primary outcome measures
- 28-day all-cause mortality [Time Frame: within 28 days after inclusion] participants will be followed up for 28 days [Time frame: Within 28 days after inclusion]
Secondary outcome measures (8)
- In-hospital mortality up to 28 days [Time frame: Within 28 days after inclusion]
- All-cause mortality up to 7 days [Time frame: Within 7 days after inclusion]
- Sequential Organ Failure Assessment (SOFA) score [Time frame: Within 28 days after inclusion]
- Hospital length of stay [Time frame: Within 28 days after inclusion]
- ICU length of stay [Time frame: Within 28 days after inclusion]
- Vasopressor utilization [Time frame: Within 28 days after inclusion]
- Progression to septic shock [Time frame: Within 28 days after inclusion]
- 28-day all-cause mortality in patients with a final diagnosis of sepsis or septic shock [Time frame: Within 28 days after inclusion]
Eligibility criteria
Inclusion criteria
- Adult patients (≥22 years of age)
- Diagnosis of sepsis or septic shock based on: the Third International Consensus Definitions (Sepsis-3 criteria) defined as at least one of the following criteria as determined by a treating physician or study physician investigator.
- Sepsis: suspected or documented infection (i.e., use or intent to use antibiotics as an indicator) and organ dysfunction defined by a Sequential Organ Failure Assessment (SOFA) score ≥2
- Septic shock: sepsis requiring vasopressors and serum lactate levels >2 mmol/L (18 mg/dL)
- Admitted or intended to be admitted to the ICU
- At least 3 mL plasma drawn and available for collection (or is anticipated to be able to be drawn and available) within 24 hours of (i.e., up to 24 hours after) the earliest diagnosis of sepsis or septic shock.
Exclusion criteria
- Prisoners or imprisonment at time of enrollment
- Prior enrollment into this study
- Informed consent as approved by IRB is unable to be obtained.
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-only
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: NCT06654895 · CES-0008