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

Mayo Clinic

Status and phase: Enrolling; Phase 2

Conditions: Low Blood Pressure; Sepsis

Treatments: Other: Standard of Care; Drug: Midodrine

Study type: Interventional

Funder types: Other

Identifiers

NCT06319248

24-000121

Details and patient eligibility

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.

Enrollment: 308 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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).

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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308 participants in 2 patient groups

Standard of Care Group

Active Comparator group

Treatment:

Other: Standard of Care

Standard of Care with Midodrine Group

Experimental group

Treatment:

Drug: Midodrine