Using Midodrine to Reduce IV Vasopressor Use in ICU Patients with Low Blood Pressure
Led by University of Alberta · Updated on 2026-01-20
870
Participants Needed
1
Research Sites
48 weeks
Total Duration
AI-Summary
What this Trial Is About
This research investigates the use of oral midodrine to reduce the need for intravenous IV vasopressors in critically ill patients with low blood pressure in the intensive care unit ICU. Vasopressors are commonly used in ICUs to support blood pressure but can cause complications such as infections and impaired mobility. The study aims to evaluate whether midodrine can help wean patients off IV vasopressors safely, improving patient outcomes and resource use in ICU settings.
Participants will be randomly assigned to receive either midodrine 10 mg orally or via nasogastric tube every 8 hours or a placebo, alongside their ongoing IV vasopressor therapy. The treatment will continue throughout the IV vasopressor use and for 24 hours after stopping it. The trial includes a pilot phase with 350 participants and a larger definitive phase with 870 participants, conducted across multiple centers with concealed allocation and blinding.
During the study, participants will be monitored for outcomes including 28-day mortality, ICU length of stay, duration of vasopressor support, ICU readmission rates, and quality of life at one year. Researchers will also assess health economic impacts such as ICU and hospital costs. Safety will be closely monitored for adverse reactions. The total participation period includes follow-up assessments up to one year after treatment.
CONDITIONS
Brief Title
Midodrine for the Early Liberation of Vasopressor Support in the ICU (LIBERATE Multi-Site)
Research Team
D
Dawn Opgenorth, RN
O
Oleksa Rewa, MD
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More than 24 hours have passed since peak vasopressor dose
Contraindication to enteral medications
Received midodrine within the last 7 days
Expected death or planned withdrawal of life-sustaining therapies within 24 hours
Pregnancy
Known allergy to midodrine medication or its components
Unable to take medications by mouth or nasogastric tube due to contraindications or intolerance
Participation limited by other medical conditions or decisions to withhold treatments
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Duration of intravenous vasopressor support plus 24 hours
Participants receive oral midodrine or placebo every 8 hours while they are on intravenous vasopressor therapy and for 24 hours after discontinuation of intravenous vasopressors.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
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.