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

ConditionVasoplegia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alberta

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Midodrine

    Drug

    10 mg PO/NG q8h

  • Placebo

    Drug

    Microcrystalline cellulose PO/NG 18h

Treatment groups

870 Participants
are divided into 2 treatment groups
Group A: MidodrineExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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

Time frame
1 year

Secondary outcomes

1

Mortality

28-day, hospital and 90-day mortality

Time frame
1 year
2

Total and post-ICU length of stay

The total duration of patient stay in hospital and the duration of hospital stay after ICU discharge

Time frame
1 year
3

Duration of vasopressor support

Duration of intravenous vasopressor support

Time frame
1 year
4

ICU readmission

Rate of ICU re-admissions during the index hospitalization

Time frame
1 year

Other outcomes

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