Recruiting

Midodrine

Sponsor:

University of Alberta

Code:

NCT05058612

Conditions

Vasoplegia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Midodrine

Placebo

Study Details

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.

Conditions

Vasoplegia

Study ID

NCT05058612

Start date

Mar 22, 2021

Status verified date

Jan, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

870 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Midodrine

Midodrine 10 mg PO/NG q8h

placebo comparator: Placebo

Microcrystalline cellulose PO/NG q8h

Interventions

Midodrine

10 mg PO/NG q8h

Placebo

Microcrystalline cellulose PO/NG 18h

Primary outcome measure

  • Hierarchical composite of 28-day mortality and ICU length of stay [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Locations

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T5R 0T1

Contacts

More Information

Sponsor

University of Alberta

Last update posted

Jan 20, 2026

Last verified

Jan, 2026

Keywords

  • critical care medicine
  • intensive care
  • shock
  • midodrine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-01-20.