Ensayos clínicos

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.
• Age greater than or equal to 18 years.
• 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 1/4/24. Questions regarding updates should be directed to the study team contact.