RecruitingPhase 4NCT05058612

Midodrine for the Early Liberation of Vasopressor Support in the ICU (LIBERATE Multi-Site)

Midodrine for the Early Liberation From Vasopressor Support in the ICU - The LIBERATE Multi-Site Study


Sponsor

University of Alberta

Enrollment

870 participants

Start Date

Mar 22, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • Age \> 18 years
  • Ongoing vasopressor support
  • Decreasing vasopressor dose(s)

Exclusion Criteria6

  • 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

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Interventions

DRUGMidodrine

10 mg PO/NG q8h

DRUGPlacebo

Microcrystalline cellulose PO/NG 18h


Locations(1)

University of Alberta Hospital

Edmonton, Alberta, Canada

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NCT05058612


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