Clinical trial

Midodrine for the Early Liberation of Vasopressor Support in the ICU - The LIBERATE Pilot Study

Name
Pro00096716
Description
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.
Trial arms
Trial start
2021-03-22
Estimated PCD
2022-07-31
Trial end
2022-10-30
Status
Completed
Phase
Early phase I
Treatment
Midodrine
10mg PO/NG q8h
Arms:
Midodrine
Other names:
Midodrine Hydrochloride
Placebo
10mg PO/NG q8h
Arms:
Placebo
Other names:
Microcrystalline cellulose
Size
20
Primary endpoint
Recruitment Rates
1 year
Duration of vasopressor support
1 year
Eligibility criteria
Inclusion Criteria: * Age \> 18 years old * ICU admission * Ongoing vasopressor support * Decreasing vasopressor dose Exclusion Criteria: * 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}
Updated at
2023-10-06

1 organization

2 products

2 indications

Product
Midodrine
Indication
Shock
Product
Placebo