Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-01-01 @ 11:23 AM
Study NCT ID:
NCT03182335
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-14
First Post:
2017-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vasopressor SAT Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}, {'id': 'D003693', 'term': 'Delirium'}, {'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2017-06-06', 'studyFirstSubmitQcDate': '2017-06-08', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in vasoactive drug dose', 'timeFrame': 'baseline thru study completion on average < 4 hrs', 'description': 'mcg/kg/min baseline dose and nadir dose'}], 'secondaryOutcomes': [{'measure': 'change in mean arterial blood pressure', 'timeFrame': 'baseline thru study completion on average <4 hrs', 'description': 'mm Hg'}, {'measure': 'change in prevalence of ICU delirium', 'timeFrame': 'baseline thru study completion on average <4hrs', 'description': 'CAM ICU score'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Blood Pressure', 'Delirium', 'Critical Illness']}, 'descriptionModule': {'briefSummary': 'To assess the impact of daily awakening from sedation on the amount of vasoactive medication required in the ICU. The hypothesis of this proposal is that the amount of vasoactive drug required to maintain an adequate mean arterial blood pressure will be reduced during a daily awakening from sedation.', 'detailedDescription': 'This observational study will compare mean arterial pressure and vasoactive drug dose recorded at two time points:\n\n1. prior to awakening from sedation\n2. during the awakening from sedation trial The vasoactive infusion will be titrated to a mean arterial pressure as determined by the medical team prior to study enrollment. Each enrolled patient will have measurements taken only on the first day of enrollment. Enrolled subjects will also have a delirium assessment using the CAM-ICU tool before the awakening from sedation trial and during the awakening from sedation trial.'}, '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\n* requiring Mechanical ventilation through an endotracheal tube with infusion of sedative or analgesic agent for comfort\n* requiring vasoactive drug via central venous catheter for the treatment of shock\n\nExclusion Criteria:\n\n* patients receiving Dexmedetomidine as sedative'}, 'identificationModule': {'nctId': 'NCT03182335', 'briefTitle': 'Vasopressor SAT Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'An Assessment of Vasoactive Medication Dose in Mechanically Ventilated Patients Undergoing Daily Sedation Awakening Trial (SAT)', 'orgStudyIdInfo': {'id': '15-1532'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mechanical Ventilation (MV) with vasoactive infusions', 'description': 'adult ICU patients who are mechanically ventilated with sedative infusion and/or analgesic infusion and also requiring vasoactive drug infusions for the treatment of shock. Patients will be excluded if receiving dexmedetomidine as sedative.', 'interventionNames': ['Other: sedation awakening trial']}], 'interventions': [{'name': 'sedation awakening trial', 'type': 'OTHER', 'otherNames': ['SAT'], 'description': 'vital signs and delirium assessment (CAM-ICU) at baseline then following routine sedation awakening trial. Patient will thus serve as their own control for these interventions', 'armGroupLabels': ['Mechanical Ventilation (MV) with vasoactive infusions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'John Kress, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}