Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2026-02-25 @ 5:53 PM
Study NCT ID:
NCT02232750
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
2014-08-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of CPD MNV as an Aid in the Diagnosis and Risk Assessment of Sepsis (Protocol # Sepsis 1-14)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012772', 'term': 'Shock, Septic'}], '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': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1320}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2015-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-01', 'studyFirstSubmitDate': '2014-08-26', 'studyFirstSubmitQcDate': '2014-09-02', 'lastUpdatePostDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'We are measuring CBC (complete blood count) and MNV (Mean Neutrophil Volume)', 'timeFrame': 'approximately 10 months', 'description': 'Evaluate the clinical utility of CPD MNV as an aid in the diagnosis and risk assessment of Emergency Department patients for progression to sepsis, severe sepsis and septic shock.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Sepsis, Severe Sepsis and Septic Shock']}, 'referencesModule': {'references': [{'pmid': '28625579', 'type': 'DERIVED', 'citation': 'Crouser ED, Parrillo JE, Seymour C, Angus DC, Bicking K, Tejidor L, Magari R, Careaga D, Williams J, Closser DR, Samoszuk M, Herren L, Robart E, Chaves F. Improved Early Detection of Sepsis in the ED With a Novel Monocyte Distribution Width Biomarker. Chest. 2017 Sep;152(3):518-526. doi: 10.1016/j.chest.2017.05.039. Epub 2017 Jun 15.'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that CPD parameters will provide improved prediction of sepsis compared to currently employed laboratory parameters. These studies hold the potential to shape practitioner guidelines and improve the timeliness and accuracy with which patients with sepsis are treated today.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Emergency Department', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (≥18 to 90 years)\n* Patients presenting to the Emergency Department\n* CBC (Complete Blood Count) with differential testing performed and CPD data retrieved\n\nExclusion Criteria:\n\n* Previously enrolled in this study'}, 'identificationModule': {'nctId': 'NCT02232750', 'acronym': 'Beckman', 'briefTitle': 'Evaluation of CPD MNV as an Aid in the Diagnosis and Risk Assessment of Sepsis (Protocol # Sepsis 1-14)', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Evaluation of CPD (Cell Population Data) MNV (Mean Neutrophil Volume) as an Aid in the Diagnosis and Risk Assessment of Sepsis (Protocol # Sepsis 1-14)', 'orgStudyIdInfo': {'id': '20141524'}}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Wexner Medical Center at The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director, Intensive Care Unit', 'investigatorFullName': 'Elliott Crouser MD', 'investigatorAffiliation': 'Ohio State University'}}}}