VENUS: Septic Gene Expression Using SeptiCyte (VENUS)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years to 89 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Critically ill subjects, admitted to an Intensive Care Unit
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)
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