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

Recruiting now · Phase 2

Conditions studied: Sepsis, Low Blood Pressure

In brief

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.

Key facts

Study ID

NCT06319248

Run by

Mayo Clinic

People needed

308

Starts

2024-05-14

Expected to finish

2029-06-30

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients diagnosed with sepsis within 24 hours of meeting all of the following criteria will be eligible to participate in the study:
• 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).

You may not qualify if…

• 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 (STEMI or NSTEMI Type 1 within the past 3 months)
• Recent treatment for peripheral vascular disease (within the past 3 months) or acute limb ischemia
• 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
• Bradycardia (heart rate < 50 beats/min)
• Untreated pheochromocytoma
• Untreated thyrotoxicosis
• Acute Angle-Closure Glaucoma
• Cirrhosis or liver failure with Child-Pugh Score > 12
• Venous blood lactate > 4
• 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

Where it is running

• Mayo Clinic Arizona — Scottsdale, Arizona, United States (enrolling)
• Mayo Clinic Florida — Jacksonville, Florida, United States (enrolling)
• Mayo Clinic Health System - Mankato — Mankato, Minnesota, United States (enrolling)
• Mayo Clinic Minnesota — Rochester, Minnesota, United States (enrolling)
• Mayo Clinic Health System - Eau Claire — Eau Claire, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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