Midodrine for the Early Liberation From Vasopressor Support in the ICU - The LIBERATE Multi-Site Study

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.

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