Using Midodrine to Help Patients with Septic Shock

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

This study is testing if giving Midodrine early can help people with septic shock keep their blood pressure up without needing as many IV medications.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 308 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Mayo Clinic (Academic / other)
• Locations: 1 site (Rochester, Minnesota)
• Trial ID: NCT06319248 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of early administration of Midodrine in patients diagnosed with septic shock. The goal is to determine if Midodrine can help maintain higher mean blood pressure without relying heavily on intravenous vasopressors. By potentially reducing the need for these medications, the study aims to improve patient outcomes, shorten hospital stays, and facilitate a smoother recovery process. Participants will be closely monitored for their response to the treatment compared to standard care.

Who should consider this trial

Good fit: Ideal candidates are patients diagnosed with sepsis who exhibit persistent low blood pressure despite initial fluid resuscitation.

Not a fit: Patients with high-dose vasopressor requirements or those with specific contraindications may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved recovery and reduced hospital stays for patients with septic shock.

How similar studies have performed: Other studies have explored the use of vasopressors in septic shock, but the specific use of Midodrine in this context is less common and may offer novel insights.

Eligibility criteria

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.

Where this trial is running

Rochester, Minnesota

• Mayo Clinic Minnesota — Rochester, Minnesota, United States (Recruiting)

Study contacts

• Principal investigator: Amos Lal, MBBS — Mayo Clinic
• Study coordinator: Aysun Tekin, M.D., M.S.

Conditions Sepsis; Low Blood Pressure; Vasopressors