Actively Recruiting
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
Eligibility Criteria
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)
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
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Trial Site Locations
Total: 1 location
1
Mayo Clinic Minnesota
Rochester, Minnesota, United States, 55905
Actively Recruiting
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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