Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-25 @ 7:08 PM
Study NCT ID:
NCT06181604
Status:
COMPLETED
Last Update Posted:
2025-08-03
First Post:
2023-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multicenter Symphony IL-6 Monitoring Sepsis ICU Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014115', 'term': 'Toxemia'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D012769', 'term': 'Shock'}], 'ancestors': [{'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 143}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2023-12-13', 'studyFirstSubmitQcDate': '2023-12-13', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '28-day all-cause mortality', 'timeFrame': 'Within 28 days after inclusion', 'description': 'Participants will be followed up for 28 days for all-cause mortality'}], 'secondaryOutcomes': [{'measure': 'In-hospital mortality up to 28 days', 'timeFrame': 'Within 28 days after inclusion', 'description': 'Participants will be followed up for 28 days for in-hospital mortality'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Interleukin-6', 'IL-6', 'Risk Stratification', 'Infections', 'Toxemia', 'Systemic Inflammatory Response Syndrome', 'Inflammation', 'Pathologic Processes', 'Sepsis', 'Septic Shock', 'Shock'], 'conditions': ['Sepsis', 'Septic Shock']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to establish an IL-6 concentration cutoff and optimal time point(s) for using Symphony IL-6 that predict 28-day mortality in patients who are admitted or are intended to be admitted to the intensive care unit (ICU) diagnosed with sepsis or septic shock.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients diagnosed with sepsis or septic shock, in accordance with the Sepsis-3 criteria, admitted or intended to be admitted to the ICU.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (≥22 years of age)\n* Diagnosis of sepsis or septic shock based on: the Third International Consensus Definitions (Sepsis-3 criteria) defined as at least one of the following criteria as determined by a treating physician or study physician investigator.\n* Admitted or intended to be admitted to the ICU\n* At least 0.4ml plasma drawn and available for collection (or is anticipated to be able to be drawn and available) within 12 hours of the earliest diagnosis of sepsis or septic shock.\n\nExclusion Criteria:\n\n* Prisoners or imprisonment at time of enrollment\n* Prior enrollment into this study\n* Informed consent as approved by IRB is unable to be obtained.'}, 'identificationModule': {'nctId': 'NCT06181604', 'acronym': 'SYMON', 'briefTitle': 'Multicenter Symphony IL-6 Monitoring Sepsis ICU Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bluejay Diagnostics, Inc.'}, 'officialTitle': 'Multicenter Symphony IL-6 Monitoring Sepsis ICU Pilot Study', 'orgStudyIdInfo': {'id': 'CES-0007'}}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University of St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '11215', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'NewYork-Presbyterian Brooklyn Methodist Hospital', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest School of Medicine', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University/Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '84111', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Intermountain Healthcare', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bluejay Diagnostics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}