SepsisVENUSNCT02127502
VENUS: Septic Gene Expression Using SeptiCyte
An observational study of Sepsis and Systemic Inflammatory Response Syndrome (SIRS), run by Immunexpress at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Sepsis, Systemic Inflammatory Response Syndrome (SIRS)
- How many people
- 379 participants
- Where
- 6 sitesUnited States
- Study dates
- Apr 2014to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill subjects, admitted to an Intensive Care Unit
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Grady Memorial Hospital
Atlanta, Georgia, 30303
Johns Hopkins Hospital
Baltimore, Maryland, 21205
Rush University Medical Center
Chicago, Illinois, 60612
Loyola University Medical Center
Maywood, Illinois, 60153
Intermountain Medical Center
Murray, Utah, 84157-7000
Northwell Health
New Hyde Park, New York, 11040
About this study
Official title: VENUS: Validation of 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.
- Medical subject headings
- Sepsis, Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients sepsis suspected | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
SeptiCyte® Lab score
Measured: 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
Measured: Subjects will be followed for the duration of their hospital stay, an expected average of 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immunexpress
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Intermountain Health Care, Inc., Johns Hopkins University, Rush University Medical Center, Northwell Health, Loyola University, Grady Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Russell R. Miller, MD, MPH, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127502
- Sponsor's protocol ID
- VENUS-1024931
- Acronym
- VENUS
- Status last verified
- Aug 2018
- First submitted
- 17 Apr 2014
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30828456Miller 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.
PubMed 29624409
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VENUS: Validation of Septic Gene ExpressioN Using SeptiCyte®
- ClinicalTrials.gov ID
- NCT02127502
- Acronym / sponsor ID
- VENUS / VENUS-1024931
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- ImmunexpressIndustry (pharma, biotech, devices)
- Collaborators
- Intermountain Health Care, Inc., Johns Hopkins University, Rush University Medical Center, Northwell Health, Loyola University, Grady Memorial Hospital
- Study start
- Apr 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 30 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients sepsis suspected | – | – |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill subjects, admitted to an Intensive Care Unit
Key inclusion criteria (6 listed)
- 18-89 years old on the day of ICU admission
- SIRS present as defined by the presence of two or more of the following:
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SeptiCyte® Lab score
Time frame: Subjects will be followed for the duration of their hospital stay, an expected average of 7 days.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- Derived from this study: PubMed 30828456Lopansri 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.
- Derived from this study: PubMed 29624409Miller 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Russell R. Miller, MD, MPH principal investigator
Intermountain Health Care, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Systemic Inflammatory Response Syndrome (SIRS), run by Immunexpress at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SeptiCyte® Lab score (time frame: Subjects will be followed for the duration of their hospital stay, an expected average of 7 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02127502, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2018.