VENUS: Validation of Septic Gene ExpressioN Using SeptiCyte®
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 379
- Locations
- 6
- Primary Endpoint
- SeptiCyte® Lab score
Study Overview
Brief Summary
The investigators seek to evaluate a new test for determining presence of infection/sepsis as compared to non-infection/systemic inflammatory response syndrome among critically ill patients within the first 24 hours of their being hospitalized in an intensive care unit (ICU) within the first 7 days of hospitalization. The primary purpose of the study is to validate SeptiCyte® Lab in this population as compared to: 1) the doctor's impression and 2) existing clinical parameters. The investigators also hope to assess how well a related, new blood test, SeptID® identifies different types of infection, as compared to cultures and other lab tests.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18-89 years old on the day of ICU admission
- •SIRS present as defined by the presence of two or more of the following:
- •Temperature > 38°C or < 36°C
- •Heart Rate > 90 beat/min
- •Tachypnea > 20/min or PaCO2 < 32 mmHg
- •White Blood Cell count > 12 000/mm3 or < 4 000/mm3 or > 10% immature neutrophils (bands)
Exclusion Criteria
- •Consent not provided
- •Age less than 18 or greater than 89 years old on the day of ICU admission
- •Not admitted to ICU
- •Clinical cultures or serologies not obtained
- •Subject has been admitted to study hospital (or transferring facility) for ≥ 24 hours
- •Elective cardiac surgery patients with an expected duration in ICU of less than 24 hours.
- •Patients on non-prophylactic antibiotics for more than 24 hours prior to ICU admission
- •Delay of >24 hours between trial enrollment and sample draw time
- •Ethnic/racial category has completed enrollment.
Outcomes
Primary Outcomes
SeptiCyte® Lab score
Time Frame: Subjects will be followed for the duration of their hospital stay, an expected average of 7 days.
Secondary Outcomes
- Comparison of SeptiCyte® Lab score to Leukocytosis, Bandemia, & procalcitonin(Subjects will be followed for the duration of their hospital stay, an expected average of 7 days.)