VENUS: Septic Gene Expression Using SeptiCyte (VENUS)

• ClinicalTrials.gov Identifier: NCT02127502
• Recruitment Status: Completed
• First Posted: April 30, 2014
• Last Update Posted: August 20, 2018
• Sponsor: Immunexpress
• Collaborators: Intermountain Health Care, Inc.; Johns Hopkins University; Rush University Medical Center; Northwell Health; Loyola University; Grady Memorial Hospital
• Information provided by (Responsible Party): Immunexpress

Study Description

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.

Condition or disease
Sepsis; Systemic Inflammatory Response Syndrome (SIRS)

Study Design

• Study Type: Observational
• Actual Enrollment: 379 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: VENUS: Validation of Septic Gene ExpressioN Using SeptiCyte®
• Study Start Date: April 2014
• Actual Primary Completion Date: August 2016
• Actual Study Completion Date: December 2016

Groups and Cohorts

Group/Cohort
Critically ill patients sepsis suspected

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Comparison of SeptiCyte® Lab score to Leukocytosis, Bandemia, & procalcitonin [ Time Frame: Subjects will be followed for the duration of their hospital stay, an expected average of 7 days. ]

Other Outcome Measures:

1. SeptID® results [ Time Frame: Subjects will be followed for the duration of their hospital stay, an expected average of 7 days. ]

Biospecimen Retention:   Samples With DNA

Blood samples will be collected

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 89 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Critically ill subjects, admitted to an Intensive Care Unit

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.

Contacts and Locations

Locations

United States, Georgia

Grady Memorial Hospital

Atlanta, Georgia, United States, 30303

United States, Illinois

Rush University Medical Center

Chicago, Illinois, United States, 60612

Loyola University Medical Center

Maywood, Illinois, United States, 60153

United States, Maryland

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21205

United States, New York

Northwell Health

New Hyde Park, New York, United States, 11040

United States, Utah

Intermountain Medical Center

Murray, Utah, United States, 84157-7000

Sponsors and Collaborators

Immunexpress

Intermountain Health Care, Inc.

Johns Hopkins University

Rush University Medical Center

Northwell Health

Loyola University

Grady Memorial Hospital

Investigators

• Principal Investigator: Russell R. Miller, MD, MPH; Intermountain Medical Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Immunexpress
• ClinicalTrials.gov Identifier: NCT02127502
• Other Study ID Numbers: VENUS-1024931
• First Posted: April 30, 2014
• Last Update Posted: August 20, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Shock