Midodrine Hydrochloride in Early Sepsis

• Status: Completed
• Trial end date: 2020-05-15
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: Cleveland Clinic Abu Dhabi
• Treatments: Midodrine

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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