VENUS: Septic Gene Expression Using SeptiCyte

Conditions

Sepsis, Systemic Inflammatory Response Syndrome (SIRS)

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.

Lopansri BK, Miller Iii RR, Burke JP, Levy M, Opal S, Rothman RE, D'Alessio FR, Sidhaye VK, Balk R, Greenberg JA, Yoder M, Patel GP, Gilbert E, Afshar M, Parada JP, Martin GS, Esper AM, Kempker JA, Narasimhan M, Tsegaye A, Hahn S, Mayo P, McHugh L, Rapisarda A, Sampson D, Brandon RA, Seldon TA, Yager TD, Brandon RB.

2019-02-2132 citations

10.1186/s40560-019-0368-2

Validation of a Host Response Assay, SeptiCyte LAB, for Discriminating Sepsis from Systemic Inflammatory Response Syndrome in the ICU

Russell R. Miller, Bert K. Lopansri, John P. Burke, Mitchell M. Levy, Steven M. Opal et al. (42 authors)

American Journal of Respiratory and Critical Care Medicine2018-04-06113 citations

10.1164/rccm.201712-2472oc

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 89 Years

Healthy volunteers

No

Inclusion criteria

1. 18-89 years old on the day of ICU admission 2. 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

1. Consent not provided 2. Age less than 18 or greater than 89 years old on the day of ICU admission 3. Not admitted to ICU 4. Clinical cultures or serologies not obtained 5. Subject has been admitted to study hospital (or transferring facility) for ≥ 24 hours 6. Elective cardiac surgery patients with an expected duration in ICU of less than 24 hours. 7. Patients on non-prophylactic antibiotics for more than 24 hours prior to ICU admission 8. Delay of \>24 hours between trial enrollment and sample draw time 9. Ethnic/racial category has completed enrollment.

Design outcomes

Primary

Measure	Time frame
SeptiCyte® Lab score	Subjects will be followed for the duration of their hospital stay, an expected average of 7 days.

Secondary

Measure	Time frame
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.

Other

Measure	Time frame
SeptID® results	Subjects will be followed for the duration of their hospital stay, an expected average of 7 days.

Countries

United States

Outcome results