Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-30 @ 7:42 AM
Study NCT ID:
NCT04552834
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-19
First Post:
2020-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alterations of the Microbiome During Critical Illness With Short and Long Term Clinical Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'stool'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2020-09-11', 'studyFirstSubmitQcDate': '2020-09-11', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'ICU re-admission', 'timeFrame': 'up to 12 months', 'description': 'number of admissions to ICU'}, {'measure': 'ICU related complications', 'timeFrame': 'up to 6 weeks', 'description': 'presence of ICU complications: including ventilator associated pneumonia, GI hemorrhage, DVT/PE, sacral decubitus ulcer, delirium, ICU acquired weakness'}, {'measure': 'Ventilator days', 'timeFrame': 'up to 4 weeks', 'description': 'duration of mechanical ventilation via endotracheal tube'}], 'primaryOutcomes': [{'measure': 'Long Term Mortality', 'timeFrame': 'up to 1 year', 'description': 'Death from any cause 90 day, 1 year'}], 'secondaryOutcomes': [{'measure': 'hospital mortality', 'timeFrame': '28 day', 'description': 'death from any cause during hospitalization'}, {'measure': 'ICU length of stay', 'timeFrame': 'hospitalization up to 6 weeks', 'description': 'number of days admitted to the ICU'}, {'measure': 'Hospital length of stay', 'timeFrame': 'hospitalization up to 6 weeks', 'description': 'number of days admitted to the hospital'}, {'measure': 'Functional Status Score', 'timeFrame': 'up to 12 months after discharge', 'description': 'Katz Index of Independence in activities of daily living; minimal score = 0; maximum score = 6; higher score better outcome'}, {'measure': 'Cognitive Dysfunction', 'timeFrame': 'Up to 12 months after discharge', 'description': 'Montreal Cognitive Assessment (MoCA) score; minimal score = 0; maximum score = 30; higher score better outcome'}, {'measure': 'Quality of Life score', 'timeFrame': 'up to 12 months after discharge', 'description': 'SF-36 score: including physical component summary (PCS) and mental component summary (MCS)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['short term outcomes', 'long term outcomes'], 'conditions': ['Critical Illness', 'Microbiome']}, 'descriptionModule': {'briefSummary': 'This study is designed to study the variations in the microbiome among critically ill patients and the effect of admission to the medical intensive care unit (MICU) at the University of Chicago. Additionally, investigators will examine the downstream clinical effects of dysbiosis in ICU patients and how patients maybe effected long term.', 'detailedDescription': 'During this study investigators will longitudinally collect discarded stool biosamples throughout the MICU admission when available. Stool Bio specimens will be recorded/coded and processed by the investigators. Stool Bio specimens will be analyzed for 16sRNA and metabolomics. Surveys will be conducted at study entry, in addition to 6 months and 12 months following discharge.\n\nBy longitudinally sampling discarded biospecimens from subjects throughout their MICU admission in additionally to describing long term following up. We will be able to correlate changes in the microbiome with clinical data, and follow up surveys to identify factors that may impact the composition of the microbiome and their impact on clinical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'adult patients admitted to the intensive care unit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nadult patients admitted to the intensive care unit\n\nExclusion Criteria: none'}, 'identificationModule': {'nctId': 'NCT04552834', 'briefTitle': 'Alterations of the Microbiome During Critical Illness With Short and Long Term Clinical Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Alterations of the Microbiome During Critical Illness With Short and Long Term Clinical Outcomes', 'orgStudyIdInfo': {'id': '20-1102'}}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Bhakti Patel', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}