NCT05058612 Midodrine for the Early Liberation of Vasopressor Support in the ICU (LIBERATE Multi-Site)
| NCT ID | NCT05058612 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Alberta |
| Condition | Vasoplegia |
| Study Type | INTERVENTIONAL |
| Enrollment | 870 participants |
| Start Date | 2021-03-22 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 870 participants in total. It began in 2021-03-22 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * Age \> 18 years * Ongoing vasopressor support * Decreasing vasopressor dose(s) Exclusion Criteria: * Greater than 24 hours from peak vasopressor dose * Contraindication to enteral medications * Previously received midodrine in last 7 days * Expected death or anticipated withdrawal of life-sustaining therapies in next 24 hours * Pregnancy * Known allergy to midodrine
Contact & Investigator
Oleksa Rewa, MD
PRINCIPAL INVESTIGATOR
University of Alberta
Frequently Asked Questions
Who can join the NCT05058612 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Vasoplegia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05058612 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05058612 currently recruiting?
Yes, NCT05058612 is actively recruiting participants. Contact the research team at dawno@ualberta.ca for enrollment information.
Where is the NCT05058612 trial being conducted?
This trial is being conducted at Edmonton, Canada.
Who is sponsoring the NCT05058612 clinical trial?
NCT05058612 is sponsored by University of Alberta. The principal investigator is Oleksa Rewa, MD at University of Alberta. The trial plans to enroll 870 participants.