VENUS: Septic Gene Expression Using SeptiCyte

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

379 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Sepsis Systemic Inflammatory Response Syndrome (SIRS)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Critically ill patients sepsis suspected

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No