NCT05058612

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
870

participants targeted

Target at P75+ for phase_4

Timeline
22mo left

Started Mar 2021

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Mar 2021Feb 2028

Study Start

First participant enrolled

March 22, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 28, 2021

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

5.9 years

First QC Date

September 16, 2021

Last Update Submit

January 15, 2026

Conditions

Vasoplegia

Keywords

critical care medicineintensive careshockmidodrine

Outcome Measures

Primary Outcomes (1)

  • 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

    1 year

Secondary Outcomes (10)

  • Mortality

    1 year

  • Total and post-ICU length of stay

    1 year

  • Duration of vasopressor support

    1 year

  • ICU readmission

    1 year

  • Re-initiation of vasopressors

    1 year

  • +5 more secondary outcomes

Study Arms (2)

Midodrine

EXPERIMENTAL

Midodrine 10 mg PO/NG q8h

Drug: Midodrine

Placebo

PLACEBO COMPARATOR

Microcrystalline cellulose PO/NG q8h

Drug: Placebo

Interventions

MidodrineDRUG

10 mg PO/NG q8h

Midodrine
PlaceboDRUG

Microcrystalline cellulose PO/NG 18h

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T5R 0T1, Canada

RECRUITING

Related Publications (1)

  • Opgenorth D, Baig N, Fiest K, Karvellas C, Kutsogiannis J, Lau V, Macintyre E, Senaratne J, Slemko J, Sligl W, Wang X, Bagshaw SM, Rewa OG. LIBERATE: a study protocol for midodrine for the early liberation from vasopressor support in the intensive care unit (LIBERATE): protocol for a randomized controlled trial. Trials. 2022 Mar 4;23(1):194. doi: 10.1186/s13063-022-06115-0.

    PMID: 35246227DERIVED

MeSH Terms

Conditions

VasoplegiaShock

Interventions

Midodrine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Study Officials

  • Oleksa Rewa, MD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dawn Opgenorth, RN

CONTACT

780 492-4698dawno@ualberta.ca

Oleksa Rewa, MD

CONTACT

780 492-6621rewa@ualberta.ca

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2021

First Posted

September 28, 2021

Study Start

March 22, 2021

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

February 1, 2028

Last Updated

January 20, 2026

Record last verified: 2026-01

Locations

CA(1)