Using midodrine to reduce IV vasopressor use in ICU patients
Midodrine for the Early Liberation From Vasopressor Support in the ICU - The LIBERATE Multi-Site Study
PHASE4 · University of Alberta · NCT05058612
This study is testing if an oral medication called midodrine can help ICU patients with low blood pressure avoid using IV medications.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 870 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alberta (other) |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT05058612 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of midodrine, an oral vasopressor, in reducing the need for intravenous (IV) vasopressors in patients with low blood pressure in the intensive care unit (ICU). The research builds on previous findings and aims to provide a safer alternative for hemodynamic support by transitioning patients from IV to oral medication. The study will involve a multi-site approach, comparing the outcomes of patients receiving midodrine versus a placebo. The goal is to improve patient care and outcomes in critical settings by minimizing the complications associated with IV vasopressor use.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are currently receiving vasopressor support and are experiencing a decrease in their vasopressor doses.
Not a fit: Patients who are not currently on vasopressor support or have contraindications to enteral medications will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more effective management of blood pressure in critically ill patients.
How similar studies have performed: Previous studies have shown promise in using oral vasopressors in non-critically ill patients, but this specific application in the ICU setting is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Edmonton, Alberta
- University of Alberta Hospital — Edmonton, Alberta, Canada (RECRUITING)
Study contacts
- Principal investigator: Oleksa Rewa, MD — University of Alberta
- Study coordinator: Dawn Opgenorth, RN
- Email: dawno@ualberta.ca
- Phone: 780 492-4698
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Vasoplegia, critical care medicine, intensive care, shock, midodrine