Clinical trial NCT02127502: VENUS: Septic Gene Expression Using SeptiCyte
Official title: VENUS: Validation of Septic Gene ExpressioN Using SeptiCyte®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Systemic Inflammatory Response Syndrome (SIRS)
Lead sponsor: Immunexpress
Sponsor class: INDUSTRY
Collaborators: name: Intermountain Health Care, Inc.
name: Johns Hopkins University
name: Rush University Medical Center
name: Northwell Health
name: Loyola University
name: Grady Memorial Hospital
First posted: 2014-04-30
Enrollment: 379
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill subjects, admitted to an Intensive Care Unit

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.


Eligibility criteria: 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.

Primary outcomes:
measure: SeptiCyte® Lab score
timeFrame: Subjects will be followed for the duration of their hospital stay, an expected average of 7 days.
Secondary outcomes:
measure: Comparison of SeptiCyte® Lab score to Leukocytosis, Bandemia, & procalcitonin
timeFrame: Subjects will be followed for the duration of their hospital stay, an expected average of 7 days.
Other outcomes:
measure: SeptID® results
timeFrame: Subjects will be followed for the duration of their hospital stay, an expected average of 7 days.
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: New Hyde Park
country: United States
facility: Northwell Health
state: New York
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
affiliation: Intermountain Medical Center
name: Russell R. Miller, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. Physician agreement on the diagnosis of sepsis in the intensive care unit: estimation of concordance and analysis of underlying factors in a multicenter cohort. J Intensive Care. 2019 Feb 21;7:13. doi: 10.1186/s40560-019-0368-2. eCollection 2019.
citation: Miller RR 3rd, Lopansri BK, Burke JP, Levy M, Opal S, Rothman RE, D'Alessio FR, Sidhaye VK, Aggarwal NR, Balk R, Greenberg JA, Yoder M, Patel G, Gilbert E, Afshar M, Parada JP, Martin GS, Esper AM, Kempker JA, Narasimhan M, Tsegaye A, Hahn S, Mayo P, van der Poll T, Schultz MJ, Scicluna BP, Klein Klouwenberg P, Rapisarda A, Seldon TA, McHugh LC, Yager TD, Cermelli S, Sampson D, Rothwell V, Newman R, Bhide S, Fox BA, Kirk JT, Navalkar K, Davis RF, Brandon RA, Brandon RB. Validation of a Host Response Assay, SeptiCyte LAB, for Discriminating Sepsis from Systemic Inflammatory Response Syndrome in the ICU. Am J Respir Crit Care Med. 2018 Oct 1;198(7):903-913. doi: 10.1164/rccm.201712-2472OC.