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
This trial does not accept healthy volunteersQualifiers
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 population
Adult patients diagnosed with sepsis or septic shock, in accordance with the sepsis-3 criteria, admitted or intended to be admitted to the ICU.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
28-day all-cause mortality [Time Frame: within 28 days after inclusion] participants will be followed up for 28 days
Participants will be followed up for 28 days for all-cause mortality
Time frame
Within 28 days after inclusionSecondary outcomes
1
In-hospital mortality up to 28 days
Participants will be followed up for 28 days for in-hospital mortality
Time frame
Within 28 days after inclusion2
All-cause mortality up to 7 days
Participants will be followed up for 7 days for all-cause mortality
Time frame
Within 7 days after inclusion3
Sequential Organ Failure Assessment (SOFA) score
SOFA score has a range from 1 to 24, where higher scores represent higher degrees of single or multiple organ failure(s).
Time frame
Within 28 days after inclusion4
Hospital length of stay
Participants will be followed up for hospital length of stay for up to 28 days
Time frame
Within 28 days after inclusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov