Midodrine Hydrochloride in Early Sepsis

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria

 Patients presenting with sepsis admitted to the ICU 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 tolerate oral medication either by mouth or by feeding tube.
  • Able to give consent for participation or have representative available to give consent.
  • Two or more blood pressure readings taken at least 15 minutes apart with MAPs ≤ 70 OR vasopressor use.
  • Two or more points scored on SOFA.
  • 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.
  • Current cardiogenic shock or KNOWN systolic heart failure with LVEF <30%.
  • Current bowel ischemia.
  • Recent Myocardial infarction (STEMI or Type 1 NSTEMI) within the past 3 months, evidence of active coronary ischemia or unstable cardiac rhythm.
  • Current use of Monoamine Oxidase Inhibitors (MAOIs).
  • Recent Stroke (within the past 3 months).
  • High dose vasopressor (norepinephrine more than 0.25 microgram/kg/min).
  • Lactate more than 8 mmol/L.
  • Midodrine use as a home medication.
  • Known allergy to midodrine.
  • Fludrocortisone acetate is a current home medication.
  • Contraindications to use: History of pheochromocytoma or thyrotoxicosis or Acute angle-closure glaucoma or ischemic bowel disease
  • History of peripheral vascular disease requiring intervention - stent or surgery in the past 3 months.

 

 

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ognjen Gajic, M.D.

Open for enrollment

Contact information:

Amy Amsbaugh R.R.T., L.R.T.

(507) 538-7538

Amsbaugh.Amy@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Pablo Moreno Franco, M.D.

Open for enrollment

Contact information:

Katelyn Register

127or7838503

Register.Katelyn@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20314309

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