NCT02127502

VENUS: Septic Gene Expression Using SeptiCyte

VENUS: Validation of Septic Gene ExpressioN Using SeptiCyte®

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 379 (actual)
• Sponsor: Immunexpress · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sepsis
• Systemic Inflammatory Response Syndrome (SIRS)

Timeline

• Start date: 2014-04-01
• Primary completion: 2016-08-01
• Completion: 2016-12-01
• First posted: 2014-04-30
• Last updated: 2018-08-20

Locations

6 sites across 1 country: United States