ClinicalTrials.gov
ClinicalTrials.gov Menu

VENUS: Septic Gene Expression Using SeptiCyte (VENUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02127502
Recruitment Status : Completed
First Posted : April 30, 2014
Last Update Posted : August 20, 2018
Sponsor:
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

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 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

Resource links provided by the National Library of Medicine


Group/Cohort
Critically ill patients sepsis suspected



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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02127502


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Immunexpress
ClinicalTrials.gov Identifier: NCT02127502     History of Changes
Other Study ID Numbers: VENUS-1024931
First Posted: April 30, 2014    Key Record Dates
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