Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-06 @ 9:30 AM
Study NCT ID:
NCT02771158
Status:
WITHDRAWN
Last Update Posted:
2017-11-06
First Post:
2016-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Midodrine During Recovery From Septic Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}, {'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008879', 'term': 'Midodrine'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study never started', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-01', 'studyFirstSubmitDate': '2016-03-28', 'studyFirstSubmitQcDate': '2016-05-10', 'lastUpdatePostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'duration of intravenous vasopressors', 'timeFrame': 'from enrollment until discontinuation of intravenous vasopressors, expected to be 3-5 days'}], 'secondaryOutcomes': [{'measure': 'intensive care unit length of stay', 'timeFrame': 'from enrollment until eligible for discharge from intensive care unit, expected to be 4-7 days'}, {'measure': 're-institution of intravenous vasopressor', 'timeFrame': 'from enrollment until hospital discharge, expected to be up to 30 days'}, {'measure': 'hospital length of stay', 'timeFrame': 'from enrollment until hospital discharge, expected to be up to 30 days'}, {'measure': 'mortality', 'timeFrame': 'from enrollment until hospital discharge, expected to be up to 30 days'}, {'measure': 'midodrine side effects requiring discontinuation', 'timeFrame': 'from enrollment until hospital discharge, expected to be up to 30 days', 'description': 'including supine hypertension and bradycardia'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['critical care', 'shock, septic', 'sepsis', 'hypotension', 'midodrine'], 'conditions': ['Hypotension', 'Shock, Septic', 'Sepsis']}, 'referencesModule': {'references': [{'pmid': '26953217', 'type': 'BACKGROUND', 'citation': 'Whitson MR, Mo E, Nabi T, Healy L, Koenig S, Narasimhan M, Mayo PH. Feasibility, Utility, and Safety of Midodrine During Recovery Phase From Septic Shock. Chest. 2016 Jun;149(6):1380-3. doi: 10.1016/j.chest.2016.02.657. Epub 2016 Mar 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether midodrine administration decreases duration of intravenous vasopressors and intensive care unit length of stay for patients in septic shock.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* admitted to intensive care unit\n* diagnosis of septic shock on intravenous vasopressors\n* stable/decreasing doses of intravenous vasopressors\n* stable/improving organ function\n\nExclusion Criteria:\n\n* allergy to midodrine\n* multiple intravenous vasopressors\n* increasing intravenous vasopressor requirements\n* worsening organ dysfunction\n* severe bradycardia'}, 'identificationModule': {'nctId': 'NCT02771158', 'briefTitle': 'Midodrine During Recovery From Septic Shock', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'A Randomized Controlled Trial of Midodrine During Recovery Phase From Septic Shock', 'orgStudyIdInfo': {'id': 'temp-1187'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'midodrine', 'description': 'randomization to midodrine 20 mg every 8 hours to be increased to a maximum of 40 mg every 8 hours until intravenous vasopressor discontinuation', 'interventionNames': ['Drug: Midodrine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'randomization to placebo control', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Midodrine', 'type': 'DRUG', 'otherNames': ['proamatine'], 'description': 'midodrine is metabolized to an active metabolite, desglymidodrine, which is an alpha adrenergic antagonist that causes vasoconstriction of both venous and arterial vasculature, thereby increasing blood pressure', 'armGroupLabels': ['midodrine']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo will be administered to double blind the study', 'armGroupLabels': ['placebo']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}