VENUS: Septic Gene Expression Using SeptiCyte
Completed
Conditions studied: Sepsis, Systemic Inflammatory Response Syndrome (SIRS)
In brief
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.
Key facts
- Study ID
- NCT02127502
- Run by
- Immunexpress
- People needed
- 379
- Starts
- 2014-04-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2018-08-20
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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.
Where it is running
- Grady Memorial Hospital — Atlanta, Georgia, United States
- Rush University Medical Center — Chicago, Illinois, United States
- Loyola University Medical Center — Maywood, Illinois, United States
- Johns Hopkins Hospital — Baltimore, Maryland, United States
- Northwell Health — New Hyde Park, New York, United States
- Intermountain Medical Center — Murray, Utah, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.