Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2026-01-01 @ 7:23 AM
Study NCT ID:
NCT04979767
Status:
UNKNOWN
Last Update Posted:
2021-07-28
First Post:
2021-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Function of Circulating Exosomes in Sepsis-induced Immunosuppression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012772', 'term': 'Shock, Septic'}, {'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_WITHOUT_DNA', 'description': 'Whole Blood, Plasma, PBMCs, Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-16', 'studyFirstSubmitDate': '2021-05-14', 'studyFirstSubmitQcDate': '2021-07-16', 'lastUpdatePostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '28-day mortality', 'timeFrame': 'From enrollment to 28 days', 'description': 'All-cause mortality'}], 'secondaryOutcomes': [{'measure': 'Hospital mortality', 'timeFrame': 'From enrollment until hospital discharge, up to 90 days', 'description': 'All-cause mortality'}, {'measure': '90-day mortality', 'timeFrame': 'From enrollment to 90 days', 'description': 'All-cause mortality'}, {'measure': 'Length of stay', 'timeFrame': 'From enrollment until hospital discharge, up to 90 days', 'description': 'Hospital length of stay'}, {'measure': 'Duration of infection', 'timeFrame': 'From enrollment until resolution of SIRS, up to 90 days', 'description': 'Time to resolution of infection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis', 'Septic Shock', 'Sepsis Syndrome', 'Sepsis Bacterial', 'Sepsis, Severe', 'Sepsis Bacteremia']}, 'descriptionModule': {'briefSummary': 'This is a single-center prospective bio-specimen analysis and observational study aiming to define immune pathways disrupted in bacterial sepsis and to identify clinically useful biomarkers of immune status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hospitalized adult patients admitted to the intensive care unit with sepsis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 50 years with ≥ 2 chronic comorbidities\n* Highly suspected bacterial infection based on clinical or radiologic evidence\n* ≥ 2 systemic inflammatory response syndrome (SIRS) criteria\n* Actual/anticipated admission to intensive care unit (ICU)\n* Anticipated length of hospital stay ≥ 5 days\n\nExclusion Criteria:\n\n* Pregnancy\n* Underlying immunosuppression (solid organ transplant, hematopoietic stem cell transplant, neutropenia, HIV infection, long-term corticosteroid use (≥ 20 mg prednisone equivalents for ≥ 14 days), immunosuppressants, radiation, chemotherapy, immune-modifying biologics, viral hepatitis, or systemic autoimmune diseases)\n* Current immunotherapy use\n* Confirmed COVID-19 infection'}, 'identificationModule': {'nctId': 'NCT04979767', 'briefTitle': 'Function of Circulating Exosomes in Sepsis-induced Immunosuppression', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Function of Circulating Exosomes in Sepsis-induced Immunosuppression', 'orgStudyIdInfo': {'id': 'STUDY#00145638'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sepsis', 'description': 'I. ≥ 50 years with ≥ 2 chronic comorbidities II. Highly suspected bacterial infection based on clinical or radiologic evidence III. ≥ 2 systemic inflammatory response syndrome (SIRS) criteria IV. Actual/anticipated admission to intensive care unit (ICU) V. Anticipated length of hospital stay ≥ 5 days'}, {'label': 'Control', 'description': 'I. ≥ 50 years with ≥ 2 chronic comorbidities II. No suspected bacterial infection III. Actual/anticipated admission to intensive care unit (ICU) IV. Anticipated length of hospital stay ≥ 5 days'}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Luigi R Boccardi, BS', 'role': 'CONTACT', 'email': 'lboccardi@kumc.edu', 'phone': '913-588-4022'}, {'name': 'Vaughn D Craddock, BS', 'role': 'CONTACT', 'email': 'vcraddock2@kumc.edu', 'phone': '316-708-7352'}, {'name': 'Leslie A Spikes, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Navneet K Dhillon, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'centralContacts': [{'name': 'Luigi R Boccardi, BS', 'role': 'CONTACT', 'email': 'lboccardi@kumc.edu', 'phone': '913-588-4022'}, {'name': 'Vaughn D Craddock, BS', 'role': 'CONTACT', 'email': 'vcraddock2@kumc.edu', 'phone': '316-708-7352'}], 'overallOfficials': [{'name': 'Nicholas S Britt, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Kansas', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Nicholas Britt', 'investigatorAffiliation': 'University of Kansas Medical Center'}}}}