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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Mayo Clinic • ClinicalTrials.gov ID: NCT06319248

Registry updated: 2026-08-31
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Description

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.

Interventions

  • Midodrine (Drug)
    Subjects will receive standard of care for sepsis and 10 mg of Midodrine every 8 hours administered orally or enterally (via nasogastric tube)
  • Standard of Care (Other)
    Subjects will receive standard of care for sepsis treatment.

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 (STEMI or NSTEMI Type 1 within the past 3 months) * Recent treatment for peripheral vascular disease (within the past 3 months) or acute limb ischemia * 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 * Bradycardia (heart rate \< 50 beats/min) * Untreated pheochromocytoma * Untreated thyrotoxicosis * Acute Angle-Closure Glaucoma * Cirrhosis or liver failure with Child-Pugh Score \> 12 * Venous blood lactate \> 4 * 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

Conditions

Sepsis Low Blood Pressure

Locations

  • Mayo Clinic Arizona — Scottsdale, Arizona, United States
  • Mayo Clinic Florida — Jacksonville, Florida, United States
  • Mayo Clinic Health System - Mankato — Mankato, Minnesota, United States
  • Mayo Clinic Minnesota — Rochester, Minnesota, United States
  • Mayo Clinic Health System - Eau Claire — Eau Claire, Wisconsin, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record