Use of Midodrine in Septic Shock Patients

Description

This study is being done to determine if early administration of Midodrine can improve outcomes by maintaining a higher mean blood pressure off of intravenous medications. Researchers want to see if Midodrine can help people with sepsis need fewer vasopressors, which could mean shorter hospital stays, less time with uncomfortable tubes, and a smoother recovery overall.

Conditions

Sepsis, Low Blood Pressure

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Study Overview

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Study Details

Study overview

This study is being done to determine if early administration of Midodrine can improve outcomes by maintaining a higher mean blood pressure off of intravenous medications. Researchers want to see if Midodrine can help people with sepsis need fewer vasopressors, which could mean shorter hospital stays, less time with uncomfortable tubes, and a smoother recovery overall.

Use of Midodrine in Septic Shock Patients

Use of Midodrine in Septic Shock Patients

Condition
Sepsis
Intervention / Treatment

-

Contacts and Locations

Rochester

Mayo Clinic Minnesota, Rochester, Minnesota, United States, 55905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Sepsis-3 criteria: acute hospital admission for suspected infection with new or worsening organ dysfunction measured by the increase in Sequential Organ failure Assessment (SOFA) score of 2 points or more.
  • * IV vasopressor use or persistent hypotension (MAP \< 65 mm Hg) after initial fluid resuscitation in the ED or ICU (30 mL/kg unless deemed excessive by the treating clinician).
  • * High-dose vasopressors (norepinephrine equivalent \> 0.3 µg/kg/min).
  • * Inadequately controlled source of infection.
  • * Cardiogenic or obstructive (massive pulmonary embolism) shock.
  • * Clinical suspicion or confirmed diagnosis of bowel obstruction, bowel ischemia, or ileus.
  • * Contraindication to enteral intake (ileus, vomiting, gastrointestinal bleeding, endoscopic procedures etc.).
  • * Recent myocardial infarction (within the past 3 months).
  • * Recent treatment for peripheral vascular disease (within the past 3 months).
  • * Current use of monoamine oxidase inhibitors.
  • * Recent stroke (within the past 3 months).
  • * Prior use of midodrine as a home medication.
  • * Known allergy to midodrine.
  • * Comfort care measures.
  • * Pregnancy.
  • * Fludrocortisone acetate as a current home medication.
  • * Bradycardia (heart rate \< 50 beats/min).
  • * Untreated pheochromocytoma.
  • * Untreated thyrotoxicosis.
  • * Open-angle glaucoma.
  • * Treating emergency or critical care physician unwilling to enroll patient in trial.
  • * Inability to give consent for participation and no representative or surrogate available to consent.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mayo Clinic,

Amos Lal, MBBS, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

2029-07-30