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MID-STEP Trial: Midodrine for Sepsis and Low Blood Pressure

This study is looking at whether an oral medication called Midodrine can help people with sepsis (a serious infection that causes organ damage) recover faster. If you have sepsis and low blood pressure, you might be eligible. Participants will receive either standard sepsis care plus Midodrine, or standard care alone. Researchers want to see if Midodrine helps you stay off intravenous (IV) blood pressure medications (vasopressors) sooner, which could mean a shorter hospital stay. The study aims to enroll 308 participants, but its current recruitment status is unclear.

Study design
This study is interventional, meaning participants will receive a specific treatment. It plans to enroll 308 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will follow participants for 28 days to see how long they are alive and off vasopressor support.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06319248

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Mayo Clinic
~308 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:MidodrineStandard of Care

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time alive and without vasopressor support
Measured over 28 days

Conditions

Sepsis
Low Blood Pressure

Explore related trials

HypotensionSepticemiaVasopressor Dependence

Where it's being run

5 sites across 4 states
Minnesota2
Arizona1
Florida1
Wisconsin1

Study leadership

  • Amos Lal, MBBS · PRINCIPAL_INVESTIGATOR · Mayo Clinic
  • Ognjen Gajic, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Amy Schuchard
[email protected]
507-255-0148
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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).

Exclusion

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

What this trial measures

  • Time alive and without vasopressor support28 days

    Measured in hours