Trial intelligence / Profile preview

LIBERATE

NCT05058612Phase 4

Key facts

Status: Recruiting
Start: Mar 2021
Primary completion: Mar 2027
Countries: 1
Sponsor: University of Alberta
Modality: Small Molecules

Drugs: midodrine
Conditions: Vasoplegia

Overview

Phase 4, randomised, double-blind trial in Vasoplegia comparing Midodrine with Placebo (2 arms). Primary endpoint: Hierarchical composite of 28-day mortality and ICU length of stay at 1 year. Started Mar 2021; status: recruiting.

Design

2 arms

Study design: RandomizedDouble-blind

Midodrine
Midodrine 10 mg PO/NG q8h
Placebo
Microcrystalline cellulose PO/NG q8h

Who it enrols

Adult patients in the ICU with vasoplegia on ongoing but decreasing intravenous vasopressor support. Excludes patients greater than 24 hours from peak vasopressor dose, those who received midodrine in the last 7 days, pregnant women, and those with expected death within 24 hours.

Endpoints

Primary

Hierarchical composite of 28-day mortality and ICU length of stay1 year

Secondary

Mortality1 year
Total and post-ICU length of stay1 year
Duration of vasopressor support1 year
ICU readmission1 year
Re-initiation of vasopressors1 year
Quality of life as measured by the EQ-5D-5L1 year
ICU costs1 year
Hospital costs1 year

Beyond the preview

Go deeper on NCT05058612.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT05058612.