Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06319248

MID-STEP (MIDodrine for Sepsis Treatment and Early vasoPressor Weaning) Trial

Led by Mayo Clinic · Updated on 2025-10-01

308

Participants Needed

1

Research Sites

271 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

MID-STEP (MIDodrine for Sepsis Treatment and Early vasoPressor Weaning) Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with sepsis within 24 hours based on Sepsis-3 criteria
  • Acute hospital admission for suspected infection with new or worsening organ dysfunction (SOFA score increase of 2 or more)
  • Use of intravenous vasopressors or persistent low blood pressure (mean arterial pressure < 65 mm Hg) after initial fluid resuscitation in the emergency department or ICU (30 mL/kg unless excessive)
Not Eligible

You will not qualify if you...

  • Use of high-dose vasopressors (norepinephrine equivalent > 0.3 g/kg/min)
  • Uncontrolled source of infection
  • Cardiogenic or obstructive shock (such as massive pulmonary embolism)
  • Suspected or confirmed bowel obstruction, ischemia, or ileus
  • Contraindications to enteral intake (ileus, vomiting, gastrointestinal bleeding, endoscopic procedures)
  • 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
  • Receiving comfort care measures
  • Pregnancy
  • Current use of fludrocortisone acetate as a home medication
  • Bradycardia (heart rate < 50 beats per minute)
  • Untreated pheochromocytoma
  • Untreated thyrotoxicosis
  • Open-angle glaucoma
  • Treating emergency or critical care physician unwilling to enroll patient
  • Inability to provide consent and no available representative or surrogate for consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mayo Clinic Minnesota

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

A

Aysun Tekin, M.D., M.S.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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MID-STEP (MIDodrine for Sepsis Treatment and Early vasoPressor Weaning) Trial | DecenTrialz