NCT06319248 · Mayo Clinic
MID-STEP (MIDodrine for Sepsis Treatment and Early vasoPressor Weaning) Trial
What this study is about
This study is being done to determine if early administration of Midodrine can improve outcomes by maintaining a higher mean blood pressure off of given through a vein (IV) 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.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Scottsdale, Arizona
- Jacksonville, Florida
- Mankato, Minnesota
- Rochester, Minnesota
- Eau Claire, Wisconsin
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 22, 2026 · Source of record for eligibility and locations