Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2026-02-25 @ 7:02 PM
Study NCT ID:
NCT02127502
Status:
COMPLETED
Last Update Posted:
2018-08-20
First Post:
2014-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VENUS: Septic Gene Expression Using SeptiCyte
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples will be collected'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 379}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-16', 'studyFirstSubmitDate': '2014-04-17', 'studyFirstSubmitQcDate': '2014-04-29', 'lastUpdatePostDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'SeptID® results', 'timeFrame': 'Subjects will be followed for the duration of their hospital stay, an expected average of 7 days.'}], 'primaryOutcomes': [{'measure': 'SeptiCyte® Lab score', 'timeFrame': 'Subjects will be followed for the duration of their hospital stay, an expected average of 7 days.'}], 'secondaryOutcomes': [{'measure': 'Comparison of SeptiCyte® Lab score to Leukocytosis, Bandemia, & procalcitonin', 'timeFrame': 'Subjects will be followed for the duration of their hospital stay, an expected average of 7 days.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis', 'Systemic Inflammatory Response Syndrome (SIRS)']}, 'referencesModule': {'references': [{'pmid': '30828456', 'type': 'DERIVED', 'citation': "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."}, {'pmid': '29624409', 'type': 'DERIVED', 'citation': "Miller 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."}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Critically ill subjects, admitted to an Intensive Care Unit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18-89 years old on the day of ICU admission\n2. SIRS present as defined by the presence of two or more of the following:\n\n * Temperature \\> 38°C or \\< 36°C\n * Heart Rate \\> 90 beat/min\n * Tachypnea \\> 20/min or PaCO2 \\< 32 mmHg\n * White Blood Cell count \\> 12 000/mm3 or \\< 4 000/mm3 or \\> 10% immature neutrophils (bands)\n\nExclusion Criteria:\n\n1. Consent not provided\n2. Age less than 18 or greater than 89 years old on the day of ICU admission\n3. Not admitted to ICU\n4. Clinical cultures or serologies not obtained\n5. Subject has been admitted to study hospital (or transferring facility) for ≥ 24 hours\n6. Elective cardiac surgery patients with an expected duration in ICU of less than 24 hours.\n7. Patients on non-prophylactic antibiotics for more than 24 hours prior to ICU admission\n8. Delay of \\>24 hours between trial enrollment and sample draw time\n9. Ethnic/racial category has completed enrollment.'}, 'identificationModule': {'nctId': 'NCT02127502', 'acronym': 'VENUS', 'briefTitle': 'VENUS: Septic Gene Expression Using SeptiCyte', 'organization': {'class': 'INDUSTRY', 'fullName': 'Immunexpress'}, 'officialTitle': 'VENUS: Validation of Septic Gene ExpressioN Using SeptiCyte®', 'orgStudyIdInfo': {'id': 'VENUS-1024931'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Critically ill patients sepsis suspected'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Grady Memorial Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loyola University Medical Center', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Health', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': '84157-7000', 'city': 'Murray', 'state': 'Utah', 'country': 'United States', 'facility': 'Intermountain Medical Center', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}], 'overallOfficials': [{'name': 'Russell R. Miller, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Intermountain Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Immunexpress', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Intermountain Health Care, Inc.', 'class': 'OTHER'}, {'name': 'Johns Hopkins University', 'class': 'OTHER'}, {'name': 'Rush University Medical Center', 'class': 'OTHER'}, {'name': 'Northwell Health', 'class': 'OTHER'}, {'name': 'Loyola University', 'class': 'OTHER'}, {'name': 'Grady Memorial Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}