Clinical Trials Logo

Clinical Trial Summary

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. The LIBERATE multi-site study will continue the work of the pilot study to evaluate the role of midodrine for patients with low blood pressure in the ICU.


Clinical Trial Description

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. Hypothesis: to evaluate the expanded role of midodrine for any vasoplegic patients in the ICU. Justification: 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. Primary Objective: To compare the effect of enteral midodrine vs. placebo in critically ill patients with vasoplegia receiving continuous IV vasopressor therapy on ICU length of stay. Secondary Objectives: To compare the effect of enteral midodrine vs. placebo on: Total and post-hospital length of stay, Duration of IV vasopressor support, 90-day all-cause mortality, Rates of ICU re-admission, Rate of re-initiation of IV vasopressors. Tertiary Objectives: To determine the health economic effects of the usage of midodrine vs placebo on: ICU costs, Hospital costs, Total healthcare costs, Cost-effectiveness. Safety Endpoints: Adverse drug reactions, Serious adverse drug reactions, Suspected unexpected serious adverse reactions. Research 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 is 350 patients (i.e., 175 patients per arm) with full follow-up. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05058612
Study type Interventional
Source University of Alberta
Contact Dawn Opgenorth, RN
Phone 780 492-4698
Email dawno@ualberta.ca
Status Recruiting
Phase Phase 4
Start date March 22, 2021
Completion date March 2025

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05922982 - Norepinephrine Weaning Guided by the Hypotension Prediction Index in Vasoplegic Shock After Cardiac Surgery N/A
Recruiting NCT04812717 - Prevention of Low Blood Pressure After Cardiac Surgery in Heart Failure Patients With a Filter Called CytoSorb. N/A
Recruiting NCT05925348 - Endotoxinemia and Vasoplegia Following Cardiothoracic Surgery With Cardiopulmonary Bypass (CPB)
Withdrawn NCT03446599 - Hemodynamic Effects of Methylene Blue vs Hydroxocobalamin in Patients at Risk of Vasoplegia During Cardiac Surgery Phase 2
Recruiting NCT02965339 - Evaluation of the Association Between Pre-existing Endothelial Dysfunction and the Onset of Vasoplegia During Cardiac Surgery With Cardiopulmonary Bypass
Not yet recruiting NCT04301479 - Low Dose Corticosteroid Infusion in Vasoplegia After Cardiac Surgery (CORTIVAS-CS) Phase 3
Recruiting NCT03968926 - Hypotension During Extracorporeal Circulatory Support Indicated for Cardiogenic Shock
Recruiting NCT04901169 - Angiotensin II in Liver Transplantation Phase 2/Phase 3
Completed NCT03744702 - Impact of Ascorbic Acid Treatment on the Development and Treatment of Vasodilation in Cardiac Surgery Early Phase 1
Not yet recruiting NCT02825056 - Postoperative Hemodynamics Comparison After High Spinal Block With or Without Intrathecal Morphine. Early Phase 1
Recruiting NCT04964492 - Assessment of the Hemodynamic Effect of Hydroxocabalamin in Refractory Vasodilatory Shock
Completed NCT03120637 - Evaluating in Cirrhotics With Refractory Vasoplegia the Effect of Methylene Blue Phase 4
Completed NCT05199493 - Reducing Acute Kidney Injury Occurence by Administering Angiotensin II Phase 3
Completed NCT05354193 - Analysis of miRNAs Expression in Vasoplegic Syndrome After On-pump Coronary Artery Bypass Surgery
Recruiting NCT05833828 - Differential Regulation of RAAS-axis in Patients Undergoing Cardiac Surgery