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Completed

NCT Number: NCT02127502

VENUS: Septic Gene Expression Using SeptiCyte

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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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Systemic Inflammatory Response Syndrome Systemic Inflammatory Response Syndrome (SIRS)

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Grady Memorial Hospital, Atlanta, Georgia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-89 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)

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. SeptiCyte® Lab score

    Time frame: 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

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

Other outcomes

  1. SeptID® results

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

Sponsors and collaborators

Lead sponsor

Immunexpress

Industry

Collaborators

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

Registry information

Official study title

VENUS: Validation of Septic Gene ExpressioN Using SeptiCyte®

Acronym: VENUS

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 30, 2014
Registry last updated
Aug 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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