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

Phase

Condition

Vascular Diseases

Soft Tissue Infections

Dizzy/fainting Spells

Treatment

Standard of Care

Placebo

Midodrine

Clinical Study ID

NCT06319248

24-000121

Ages > 18
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 orworsening organ dysfunction measured by the increase in Sequential Organ failureAssessment (SOFA) score of 2 points or more.
IV vasopressor use or persistent hypotension (MAP < 65 mm Hg) after initial fluidresuscitation in the ED or ICU (30 mL/kg unless deemed excessive by the treatingclinician).

Exclusion

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, orileus.
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 surrogateavailable to consent.

Study Design