VENUS: Septic Gene Expression Using SeptiCyte (VENUS)

VENUS: Validation of Septic Gene ExpressioN Using SeptiCyte®

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Systemic Inflammatory Response Syndrome (SIRS)

• Study Type: Observational
• Enrollment (Actual): 379

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Grady Memorial Hospital
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins Hospital
  • New York
    • New Hyde Park, New York, United States, 11040
      • Northwell Health
  • Utah
    • Murray, Utah, United States, 84157-7000
      • Intermountain Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Critically ill subjects, admitted to an Intensive Care Unit

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Critically ill patients sepsis suspected

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Immunexpress
• Collaborators: Johns Hopkins University; Northwell Health; Rush University Medical Center; Intermountain Health Care, Inc.; Loyola University; Grady Memorial Hospital
• Investigators: Principal Investigator: Russell R. Miller, MD, MPH, Intermountain Medical Center

Publications and helpful links

General Publications

• 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. Erratum In: Am J Respir Crit Care Med. 2020 Jul 1;202(1):155.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: April 17, 2014
• First Submitted That Met QC Criteria: April 29, 2014
• First Posted (Estimate): April 30, 2014

Study Record Updates

• Last Update Posted (Actual): August 20, 2018
• Last Update Submitted That Met QC Criteria: August 16, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Shock; Systemic Inflammatory Response Syndrome
• Other Study ID Numbers: VENUS-1024931

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No