Midodrine Hydrochloride in Early Sepsis

Completed · Phase 1 · Has a placebo group

Conditions studied: Sepsis, Blood Pressure

In brief

The investigators would like to determine if early administration of oral Midodrine in participants diagnosed with sepsis will impact blood pressures and decrease the need for and/or doses of intravenous pressor agents.

Key facts

Study ID

NCT03129542

Run by

Mayo Clinic

People needed

33

Starts

2017-08-30

Expected to finish

2020-05-15

Last updated by the study team

2021-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients diagnosed with sepsis based on the old Sepsis criteria and meeting all of the following criteria will be considered eligible to participate in the study.
• Age greater than or equal to 18 years
• Able to safely tolerate medication either by mouth or feeding tube (i.e. absence of nausea or vomiting)
• Able to give consent for participation or have representative available
• Two or more blood pressure readings taken at least 15 minutes apart with mean arterial pressures, MAPs 70 or less
• Treating consultant agrees to the study plan

You may not qualify if…

• Patients meeting any one of the following criteria will be excluded from participation:
• Women of child bearing age with the potential to become pregnant who do not have a clinically documented negative pregnancy test
• Current cardiogenic shock or known systolic heart failure with left ventricular ejection fraction (LVEF) < 30%
• Current bowel ischemia
• Recent Myocardial infarction within the past 3 months
• Current use of Monoamine Oxidase Inhibitors (MAOIs)
• Recent Stroke within the past 3 months
• Midodrine as a home medication
• Known allergy to Midodrine
• High dose vasopressor use (norepinephrine >0.25 mcg/kg/min)
• Lactate more than 8 mmol/L
• Contraindications to use: History of pheochromocytoma or thyrotoxicosis or glaucoma or ischemic bowel disease

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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