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Midodrine for the Early Liberation of Vasopressor Support in the ICU (LIBERATE Multi-Site)

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Secondary endpoints: details revised at 1 of 10 entriesv10
  2. Study description revisedv9
  3. Primary endpoint revised
    • Enrollment target: 850 to 870
    • Secondary endpoints: 9 to 10
    • Study description expanded, about 10 words
    v8
  4. Study description expanded, about 21 wordsv7
  5. Enrollment target: 350 to 850v6 Show 5 more changesShow less
    • Primary completion date: Dec 2024 to Mar 2027
    • Primary endpoint revised
    • Study completion date: Mar 2025 to Feb 2028
    • Secondary endpoints: details revised at 1 of 9 entries
    • Study description expanded, about 19 words
Show 4 earlier versionsHide 4 earlier versions
  1. Primary completion date: Dec 2023 to Dec 2024
    • Study completion date: Mar 2024 to Mar 2025
    v5
  2. 2 versions Re-verified since Oct 24, 2022, no change to tracked fieldsv3-v4
  3. Secondary endpoints: details revised at 2 of 9 entriesv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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. This 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.
Trial Details
NCT Number NCT05058612
Lead Sponsor University of Alberta
Collaborators: University Hospital Foundation, Institute of Health Economics, Canada, Alberta Health services
Conditions
(from sponsor)		 Vasoplegia
Related terms Shock, Vasoplegia
Enrollment 870 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov