VENUS: Septic Gene Expression Using SeptiCyte

NCT02127502 | Completed

• 1 other identifier: VENUS-1024931
• Study Type: observational
• Target: 379
• Locations: 1 country
• Sites: 6

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.

Conditions

Sepsis; Systemic Inflammatory Response Syndrome (SIRS)

Outcome Measures

Primary Outcomes (1)

• SeptiCyte® Lab score

  Subjects will be followed for the duration of their hospital stay, an expected average of 7 days.

Secondary Outcomes (1)

• 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 Outcomes (1)

• SeptID® results

  Subjects will be followed for the duration of their hospital stay, an expected average of 7 days.

Study Arms (1)

Critically ill patients sepsis suspected

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill subjects, admitted to an Intensive Care Unit

You may qualify if:

• years old on the day of ICU admission
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Immunexpress: lead
• Intermountain Health Care, Inc.: collaborator
• Johns Hopkins University: collaborator
• Rush University Medical Center: collaborator
• Northwell Health: collaborator
• Loyola University: collaborator
• Grady Memorial Hospital: collaborator

Study Sites (6)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

Northwell Health

New Hyde Park, New York, 11040, United States

Location

Intermountain Medical Center

Murray, Utah, 84157-7000, United States

Location

Related Publications (2)

• 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.

  PMID: 30828456 DERIVED

• 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.

  PMID: 29624409 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected

MeSH Terms

Conditions

Sepsis; Systemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Russell R. Miller, MD, MPH

  Intermountain Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2014
• First Posted: April 30, 2014
• Study Start: April 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 20, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)