Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-01-04 @ 5:09 PM
Study NCT ID:
NCT04819035
Status:
COMPLETED
Last Update Posted:
2022-07-18
First Post:
2021-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sepsis Post Market Clinical Utility Simple Endpoint Study - Indiana University Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D004194', 'term': 'Disease'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 127}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-15', 'studyFirstSubmitDate': '2021-03-24', 'studyFirstSubmitQcDate': '2021-03-25', 'lastUpdatePostDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Health & Economic Benefits for Hospital Stay - Simulated', 'timeFrame': 'Within 12 hours from presentation to the emergency department', 'description': "Monocyte Distribution Width's \\[MDW\\] ability to reduce length of hospital stay by earlier detection of sepsis by using AUC (Area Under The Curve) ROC (Receiver Operating Characteristics) curve."}, {'measure': 'Health & Economic Benefits for Intensive Care Unit Stay - Simulated', 'timeFrame': 'Within 12 hours from presentation to the emergency department', 'description': "Monocyte Distribution Width's \\[MDW\\] ability to reduce length of intensive care unit stay by earlier detection of sepsis by using AUC (Area Under The Curve) ROC (Receiver Operating Characteristics) curve."}, {'measure': 'Health & Economic Benefits for Mortality - Simulated', 'timeFrame': 'Within 12 hours from presentation to the emergency department', 'description': "Monocyte Distribution Width's \\[MDW\\] ability to reduce in-house mortality by earlier detection of sepsis by using AUC (Area Under The Curve) ROC (Receiver Operating Characteristics) curve."}], 'primaryOutcomes': [{'measure': 'Potential reduction of Time to Antibiotics Ordered and Administered', 'timeFrame': 'Within 12 hours from presentation to the emergency department', 'description': "Monocyte Distribution Width's \\[MDW\\] ability to reduce time to first antibiotics ordered by physician (decision to treat) and first antibiotics administered via a simulation"}], 'secondaryOutcomes': [{'measure': 'Performance', 'timeFrame': 'Within 12 hours from presentation to the emergency department', 'description': "Monocyte Distribution Width's \\[MDW\\] ability to identify Sepsis vs Non-Sepsis when using a Sepsis electronic medical record definition using AUC (Area Under The Curve) ROC (Receiver Operating Characteristics) curve."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Sepsis', 'Adult Disease', 'Severe Sepsis', 'Emergency Department']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to demonstrate that addition of the Monocyte Width Distribution (MDW) parameter to current standard of care improves a clinician's ability to recognize sepsis in the Emergency Department, resulting in earlier decision to administer antibiotics from time of ED presentation for sepsis patients (simulated primary endpoint), with concomitant reductions in length of stay and in-hospital mortality for those patients (secondary endpoints).", 'detailedDescription': 'The objective of this study is to develop a method for identifying sepsis patients from electronic health records (EHR) based on Sepsis-2 criteria. Sepsis patients will be identified using a Sepsis Definition which includes meeting SIRS score of ≥2 within 12 hours of ED presentation and any microbial testing ordered within 24 hours of ED presentation. The patient will be enrolled if it meets the Sepsis Definition and additional EMR data elements will be extracted to complete case report form. Furthermore, objectives include to confirm the clinical validity and performance of MDW in a control population of sepsis patients where MDW is measured but not reported to physicians. This study is an observational study which will simulate the decision impact of MDW on sepsis identification and patient management'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients presenting to the ED where a CBC-Diff has been ordered by standard of care', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (18 to 89 years)\n* All race and ethnicities\n* Presenting to the emergency department with suspicion of infection\n* Whose assessment includes a CBC with differential\n* Meets EMR Sepsis Definition\n\nExclusion Criteria:\n\n* Pregnancy\n* Prisoners\n* Transfers from other ED\n* Previously enrolled'}, 'identificationModule': {'nctId': 'NCT04819035', 'briefTitle': 'Sepsis Post Market Clinical Utility Simple Endpoint Study - Indiana University Hospital', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beckman Coulter, Inc.'}, 'officialTitle': 'Post Market Clinical Utility of ESId (MDW Hematology Parameter) for Early Sepsis Detection in the Emergency Department (US Hospitals) - Indiana University Hospital', 'orgStudyIdInfo': {'id': 'C54020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CBC-Diff Monocyte Volume Width Distribution', 'description': 'Monocyte Volume Width Distribution (MDW) is part of the CBC with Differential', 'interventionNames': ['Diagnostic Test: CBC-DIFF Monocyte Volume Width Distribution (MDW)']}], 'interventions': [{'name': 'CBC-DIFF Monocyte Volume Width Distribution (MDW)', 'type': 'DIAGNOSTIC_TEST', 'description': 'MDW measurement will be used to detect sepsis. Results will not be used to manage patients.', 'armGroupLabels': ['CBC-Diff Monocyte Volume Width Distribution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Methodist Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Magdalena Czader, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beckman Coulter, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}