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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified April 2026 by Mayo Clinic
Sponsor
Mayo Clinic
Information Provided by (Responsible Party)
Ognjen Gajic
Clinicaltrials.gov Identifier
NCT06319248
Other Study ID Numbers:
24-000121
First Submitted
March 12, 2024
First Posted
March 19, 2024
Last Update Posted
May 21, 2026
Last Verified
April 2026

ClinicalTrials.gov processed this data on May 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
SepsisLow Blood Pressure
Other: Standard of CareDrug: Midodrine

Study Design

Study TypeInterventional
Actual Enrollment308 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleMID-STEP (MIDodrine for Sepsis Treatment and Early vasoPressor Weaning) Trial
Study Start DateMay 13, 2024
Actual Primary Completion Date2yrs 10mos from now
Actual Study Completion Date3yrs 1mo from now

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures
  1. Time alive and without vasopressor support
    Measured in hours
Secondary Outcome Measures
  1. Total vasopressor requirements
    Measured as norepinephrine equivalents (µg)
  2. Central venous access duration
    Measured in hours
  3. Cumulative fluid balance over the first 48 hours
  4. Cumulative fluid balance up to 7 days of ICU stay
  5. ICU Length of Stay
    Total number of days admitted to the Intensive Care Unit (ICU)
  6. Hospital Length of Stay
    Total number of days admitted to the hospital
  7. ICU, hospital, and organ support-free days
    Number of ICU, hospital, and organ support-free days

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion 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
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

Contacts and Locations

Sponsors and CollaboratorsMayo Clinic
Locations
Mayo Clinic Arizona | Scottsdale Arizona, United States, 85259Mayo Clinic Florida | Jacksonville Florida, United States, 32224Mayo Clinic Health System - Mankato | Mankato Minnesota, United States, 56001Mayo Clinic Minnesota | Rochester Minnesota, United States, 55905Mayo Clinic Health System - Eau Claire | Eau Claire Wisconsin, United States, 54703
Investigators
Principal Investigator: Amos Lal, MBBS, Mayo ClinicPrincipal Investigator: Ognjen Gajic, MD, Mayo Clinic