MID-STEP (MIDodrine for Sepsis Treatment and Early vasoPressor Weaning) Trial
Mayo Clinic
308 participants
May 14, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria20
- 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.
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Interventions
Subjects will receive standard of care for sepsis and 10 mg of Midodrine every 8 hours administered orally or enterally (via nasogastric tube)
Subjects will receive standard of care for sepsis treatment.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06319248