About this trial
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
This trial accepts healthy volunteersQualifiers
Age > 18 years
Ongoing vasopressor support
Decreasing vasopressor dose(s)
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Midodrine
Drug10 mg PO/NG q8h
Placebo
DrugMicrocrystalline cellulose PO/NG 18h
Treatment groups
Trial outcomes
Primary outcomes
Hierarchical composite of 28-day mortality and ICU length of stay
The effects of midodrine on patient mortality at 28 days or total duration of patient stay in ICU
Secondary outcomes
Mortality
28-day, hospital and 90-day mortality
Total and post-ICU length of stay
The total duration of patient stay in hospital and the duration of hospital stay after ICU discharge
Duration of vasopressor support
Duration of intravenous vasopressor support
ICU readmission
Rate of ICU re-admissions during the index hospitalization
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alberta
Lead sponsor
University Hospital Foundation
Collaborator
Institute of Health Economics, Canada
Collaborator
Alberta Health services
Collaborator