Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 5:44 PM
Study NCT ID:
NCT05684133
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2023-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
REMISE Study: REMnant Biospecimen Investigation in SEpsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Remnant/leftover blood samples collected after usual patient care in comparison to newly obtained blood samples to evaluate 1) validity and stability of remnant blood samples vs fresh, newly obtained blood samples. 2) blood proteins, biomarkers, and other -omics'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-27', 'studyFirstSubmitDate': '2023-01-04', 'studyFirstSubmitQcDate': '2023-01-04', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in traditional biomarkers, proteomics, pathogen sequencing, and metabolomics/lipidomics between prospectively collected biospecimens and remnant biospecimens.', 'timeFrame': '01/2024'}], 'secondaryOutcomes': [{'measure': 'Measurement of traditional biomarkers in all samples', 'timeFrame': '1/2024', 'description': 'Traditional biomarkers to be measured in remnant and research specimens including inflammatory and endothelial-related biomarkers.'}, {'measure': 'Measurement of proteomics in all samples', 'timeFrame': '1/2024', 'description': 'Proteomics to be measured in remnant and research specimens to capture over 50 different plasma proteins.'}, {'measure': 'Measurement of metabolomics/lipidomics in all samples', 'timeFrame': '1/2024', 'description': 'Metabolomics and lipidomics to be measured in remnant and research specimens to capture organic acids, amino acids, and phospholipids.'}, {'measure': 'Pathogen sequencing in all samples', 'timeFrame': '1/2024', 'description': 'Pathogen sequencing will be performed on all remnant and research specimens to precisely identify the causative strain(s) in the infection.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis']}, 'descriptionModule': {'briefSummary': 'In the REMISE is study, we will compare blood proteins, biomarkers, and other -omics prospectively collected from patients with sepsis from two sources, i.) remnant (discarded) samples from the clinical laboratory, and ii.) prospectively collected in UPMC Presbyterian hospital research coordinator specimen collected biospecimens.\n\nAnalyses will include traditional biomarkers, quantitative proteomics, metabolomics, lipidomics, transcriptomics, and pathogen genomic sequencing in both sets of samples. This data will allow the assessment of the feasibility, integrity, and scientific value of remnant samples compared to research coordinator samples collected at the bedside for mechanistic sepsis research.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with Sepsis-3 presenting to eligible emergency departments.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient, at least 18 years of age\n* Meeting Sepsis-3 criteria within 6 hours of admission\n* Biospecimens obtained for routine clinical care and measurement\n* Peripheral intravenous access\n\nExclusion Criteria:\n\n* Patients who do not have Sepsis-3\n* Traumatic injury,\n* Inability to consent or contact legal representative,\n* Cardiac arrest,\n* Stroke,\n* Comfort measures only,\n* Unable to obtain intravenous access, and/or\n* Subject declines to participate.\n* No residual blood left in clinical sample'}, 'identificationModule': {'nctId': 'NCT05684133', 'acronym': 'REMISE', 'briefTitle': 'REMISE Study: REMnant Biospecimen Investigation in SEpsis', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'REMISE Study: REMnant Biospecimen Investigation in SEpsis', 'orgStudyIdInfo': {'id': 'STUDY21120013'}, 'secondaryIdInfos': [{'id': '5R21GM144851-02', 'link': 'https://reporter.nih.gov/quickSearch/5R21GM144851-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Sepsis', 'description': 'Adult patients (18 years or older) meeting Sepsis-3 criteria within 6 hours of emergency department admission. Patients will be excluded with the following conditions: traumatic injury, cardiac arrest, stroke, comfort measures only.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Christopher Seymour, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh / UPMC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vanderbilt University', 'class': 'OTHER'}, {'name': 'National Institute of General Medical Sciences (NIGMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Dept. of Critical Care Medicine, University of Pittsburgh School of Medicine Associate Professor, Depts. of Emergency Medicine & Clinical Translational Science The CRISMA Center, Director, Translational and Clinical Science Program', 'investigatorFullName': 'Christopher Seymour', 'investigatorAffiliation': 'University of Pittsburgh'}}}}