Midodrine for the Early Liberation of Vasopressor Support in the ICU

NCT04489589 | Completed Phase 4

• 1 other identifier: Pro00096716
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 The LIBERATE pilot study will evaluate the role of midodrine for patients with low blood pressure in the ICU. The investigators are planning on enrolling up to 20 study participants to evaluate this question in the General Systems ICU at the University of Alberta Hospital.

Conditions

Critical Illness; Shock

Outcome Measures

Primary Outcomes (2)

• Recruitment Rates

  Recruitment metrics by patients recruitment and consent rate

  1 year

• Duration of vasopressor support

  Duration of intravenous vasopressor support

  1 year

Secondary Outcomes (5)

• ICU length of stay

  1 year

• Mortality

  Up to 90 days

• Re-initiation of IV vasopressors

  1 year

• ICU re-admissions

  1 year

• Adverse events

  1 year

Study Arms (2)

Midodrine

EXPERIMENTAL

Midodrine 10mg PO/NG q8h

Drug: Midodrine

Placebo

PLACEBO COMPARATOR

Microcrystalline cellulose PO/NG q8h

Drug: Placebo

Interventions

Midodrine DRUG

10mg PO/NG q8h

Also known as: Midodrine Hydrochloride

Midodrine

Placebo DRUG

10mg PO/NG q8h

Also known as: Microcrystalline cellulose

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years old
• ICU admission
• Ongoing vasopressor support
• Decreasing vasopressor dose

You may not qualify if:

• Greater than 24 hours from peak vasopressor dose
• Contraindication to enteral medications
• Previously on midodrine in last 7 days
• Expected death or withdrawal of life-sustaining therapies
• Pregnancy
• Known allergy to Midodrine

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Health services: collaborator
• Institute of Health Economics, Canada: collaborator

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T5R0T1, Canada

Location

Related Publications (1)

• Kilcommons SJ, Hammal F, Opgenorth DL, Fiest KM, Karvellas CJ, Lau VI, MacIntyre E, Senaratne J, Slemko J, Sligl W, Zampieri F, Duquette D', Guan LT, Baig N, Bagshaw SM, Rewa OG. Midodrine for the early liberation from vasopressor support in the ICU (LIBERATE): a feasibility study. Pilot Feasibility Stud. 2024 Dec 4;10(1):147. doi: 10.1186/s40814-024-01577-2.

  PMID: 39633467 DERIVED

MeSH Terms

Conditions

Critical Illness; Shock

Interventions

Midodrine; microcrystalline cellulose

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Oleksa G Rewa, MD MSc

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 28, 2020
• Study Start: March 22, 2021
• Primary Completion: July 31, 2022
• Study Completion: October 30, 2022
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)