Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study
ConditionSepsis, Septic Shock
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorBluejay Diagnostics, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
Prisoners or imprisonment at time of enrollment
Prior enrollment into this study
Informed consent as approved by IRB is unable to be obtained.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Source ClinicalTrials.gov