VENUS: Septic Gene Expression Using SeptiCyte

Sepsis Clinical Trial

— VENUS  

Official title:

VENUS: Validation of Septic Gene ExpressioN Using SeptiCyte®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02127502
• Other study ID #: VENUS-1024931
• Status: Completed
• Start date: April 2014
• Est. completion date: December 2016

Study information

• Verified date: August 2018
• Source: Immunexpress
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 379
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sepsis
• Systemic Inflammatory Response Syndrome
• Systemic Inflammatory Response Syndrome (SIRS)

Locations

Country	Name	City	State
United States	Grady Memorial Hospital	Atlanta	Georgia
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Rush University Medical Center	Chicago	Illinois
United States	Loyola University Medical Center	Maywood	Illinois
United States	Intermountain Medical Center	Murray	Utah
United States	Northwell Health	New Hyde Park	New York

Sponsors (7)

Lead Sponsor	Collaborator
Immunexpress	Grady Memorial Hospital, Intermountain Health Care, Inc., Johns Hopkins University, Loyola University, Northwell Health, Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	SeptID® results		Subjects will be followed for the duration of their hospital stay, an expected average of 7 days.
Primary	SeptiCyte® Lab score		Subjects will be followed for the duration of their hospital stay, an expected average of 7 days.
Secondary	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.