Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT05058612
Status:
RECRUITING
Last Update Posted:
2025-10-01
First Post:
2021-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Midodrine for the Early Liberation of Vasopressor Support in the ICU (LIBERATE Multi-Site)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056987', 'term': 'Vasoplegia'}, {'id': 'D012769', 'term': 'Shock'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 870}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2021-09-16', 'studyFirstSubmitQcDate': '2021-09-16', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hierarchical composite of 28-day mortality and ICU length of stay', 'timeFrame': '1 year', 'description': 'The effects of midodrine on patient mortality at 28 days or total duration of patient stay in ICU'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '1 year', 'description': '28-day, hospital and 90-day mortality'}, {'measure': 'Total and post-ICU length of stay', 'timeFrame': '1 year', 'description': 'The total duration of patient stay in hospital and the duration of hospital stay after ICU discharge'}, {'measure': 'Duration of vasopressor support', 'timeFrame': '1 year', 'description': 'Duration of intravenous vasopressor support'}, {'measure': 'ICU readmission', 'timeFrame': '1 year', 'description': 'Rate of ICU re-admissions during the index hospitalization'}, {'measure': 'Re-initiation of vasopressors', 'timeFrame': '1 year', 'description': 'Rate of re-initiation of intravenous vasopressors during ICU stay'}, {'measure': 'Quality of life as measured by the EQ-5D-5L', 'timeFrame': '1 year'}, {'measure': 'ICU costs', 'timeFrame': '1 year', 'description': 'Total cost of ICU stay'}, {'measure': 'Hospital costs', 'timeFrame': '1 year', 'description': 'Total cost of hospital stay'}, {'measure': 'Total health care costs', 'timeFrame': '1 year', 'description': 'Total healthcare costs'}, {'measure': 'Cost effectiveness', 'timeFrame': '1 year', 'description': 'Incremental costs and effectiveness based on daily ICU costs'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['critical care medicine', 'intensive care', 'shock', 'midodrine'], 'conditions': ['Vasoplegia']}, 'referencesModule': {'references': [{'pmid': '35246227', 'type': 'DERIVED', 'citation': 'Opgenorth D, Baig N, Fiest K, Karvellas C, Kutsogiannis J, Lau V, Macintyre E, Senaratne J, Slemko J, Sligl W, Wang X, Bagshaw SM, Rewa OG. LIBERATE: a study protocol for midodrine for the early liberation from vasopressor support in the intensive care unit (LIBERATE): protocol for a randomized controlled trial. Trials. 2022 Mar 4;23(1):194. doi: 10.1186/s13063-022-06115-0.'}]}, 'descriptionModule': {'briefSummary': 'Vasopressors are medications that are given intravenously to increase the blood pressure of patients with illnesses that cause dangerous blood pressure drops. When a doctor prescribes a vasopressor, they ask that the dose be adjusted to achieve a specific blood pressure. This kind of medical support with intravenous (IV) vasopressors are usual treatments in intensive care unit (ICU) settings. Oral vasopressors, such as midodrine, have been historically used to maintain blood pressure in non-critically ill patients. In this study, the investigators will be using midodrine to reduce the need for IV vasopressors as blood pressure improves during the stay in the ICU.\n\nThis LIBERATE multi-site study will continue the work of the LIBERATE feasibility RCT study to evaluate the role of midodrine for patients with low blood pressure in the ICU. It is comprised of the multi centre pilot RCT followed by the definitive multi centre RCT.', 'detailedDescription': 'Purpose: Resuscitation and hemodynamic support with intravenous (IV) vasopressors is a prime indication of treatment in intensive care unit (ICU) settings. Hemodynamic support is typically provided with intravenous (IV) vasopressors. However, these have been shown to have significant negative effects including increased central venous catheter line associated infections, venous thromboembolic disease, impaired mobility and gastrointestinal injury and ischemia. Oral vasopressors, such as midodrine, have been historically used for hemodynamic support in non-critically ill patients, but their study in patients as IV pressor sparing therapy has been limited.\n\nHypothesis: to evaluate the expanded role of midodrine for any vasoplegic patients in the ICU.\n\nJustification: In 2018, there were 1,613 admissions to the adult general systems ICU (GSICU) at the University of Alberta Hospital (UAH). Patients were sick, with a mean Acute Physiology and Chronic Health Evaluation II (APACHE) score of 21.3, with 36.4% requiring vasopressors on admission, accounting for 1942 patient-days (data from eCritical TRACER database). In the environment strained healthcare resources and limited ICU capacity, the ability to safely wean patients from IV vasopressors with transition to oral hemodynamic supporting agents would greatly improve how patients navigate through the healthcare system. This in turn will improve patient-centered case.\n\nPrimary Objective:\n\nTo compare the effect of enteral midodrine vs. placebo in critically ill patients with vasoplegia receiving continuous IV vasopressor therapy on a hierarchical composite of 28-day mortality and ICU length of stay.\n\nSecondary Objectives: To compare the effect of enteral midodrine vs. placebo on: 28-day, hospital, and 90-day mortality, Duration of IV vasopressor support, Rates of ICU re-admission, Rate of re-initiation of IV vasopressors, and Quality of life at one year.\n\nTertiary Objectives: To determine the health economic effects of the usage of midodrine vs placebo on: ICU costs, Hospital costs, Total healthcare costs, Cost-effectiveness.\n\nSafety Endpoints: Adverse drug reactions, Serious adverse drug reactions, Suspected unexpected serious adverse reactions.\n\nResearch Method/Procedures: The LIBERATE Trial is a multi center, concealed-allocation parallel-group blinded randomized controlled trial. Patients will be randomly assigned to midodrine (enteral, 10mg every 8h) or placebo (microcrystalline cellulose) for the duration of their IV vasopressor therapy and 24h following the discontinuation of their IV vasopressor therapy. The recruitment target for the multi centre pilot RCT is 350 subjects (i.e., 175 subjects per arm), followed by the definitive RCT with a recruitment target of 850 subjects (425 subjects per arm). A blinded multi site pilot analysis will be conducted after the enrolment of the first 20% of study subjects (170 subjects).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Ongoing vasopressor support\n* Decreasing vasopressor dose(s)\n\nExclusion Criteria:\n\n* Greater than 24 hours from peak vasopressor dose\n* Contraindication to enteral medications\n* Previously received midodrine in last 7 days\n* Expected death or anticipated withdrawal of life-sustaining therapies in next 24 hours\n* Pregnancy\n* Known allergy to midodrine'}, 'identificationModule': {'nctId': 'NCT05058612', 'briefTitle': 'Midodrine for the Early Liberation of Vasopressor Support in the ICU (LIBERATE Multi-Site)', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'Midodrine for the Early Liberation From Vasopressor Support in the ICU - The LIBERATE Multi-Site Study', 'orgStudyIdInfo': {'id': 'Pro00112293'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Midodrine', 'description': 'Midodrine 10 mg PO/NG q8h', 'interventionNames': ['Drug: Midodrine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Microcrystalline cellulose PO/NG q8h', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Midodrine', 'type': 'DRUG', 'description': '10 mg PO/NG q8h', 'armGroupLabels': ['Midodrine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Microcrystalline cellulose PO/NG 18h', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T5R 0T1', 'city': 'Edmonton', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Dawn Opgenorth, RN', 'role': 'CONTACT', 'email': 'dawno@ualberta.ca', 'phone': '780 492-4698'}, {'name': 'Oleksa Rewa, MD', 'role': 'CONTACT', 'email': 'rewa@ualberta.ca', 'phone': '780 492-6621'}], 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'centralContacts': [{'name': 'Dawn Opgenorth, RN', 'role': 'CONTACT', 'email': 'dawno@ualberta.ca', 'phone': '780 492-4698'}, {'name': 'Oleksa Rewa, MD', 'role': 'CONTACT', 'email': 'rewa@ualberta.ca', 'phone': '780 492-6621'}], 'overallOfficials': [{'name': 'Oleksa Rewa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital Foundation', 'class': 'OTHER'}, {'name': 'Institute of Health Economics, Canada', 'class': 'OTHER'}, {'name': 'Alberta Health services', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}