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

August 27, 2026 updated by: Ognjen Gajic, Mayo Clinic
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

308

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Recruiting
        • Mayo Clinic Arizona
        • Contact:
        • Sub-Investigator:
          • Rodrigo Cartin-Ceba, MD
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic Florida
        • Contact:
        • Sub-Investigator:
          • Devang K. Sanghavi, MBBS, MD
    • Minnesota
      • Mankato, Minnesota, United States, 56001
        • Recruiting
        • Mayo Clinic Health System - Mankato
        • Contact:
        • Principal Investigator:
          • Amos Lal, MBBS
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic Minnesota
        • Principal Investigator:
          • Ognjen Gajic, MD
        • Contact:
        • Principal Investigator:
          • Amos Lal, MBBS
    • Wisconsin
      • Eau Claire, Wisconsin, United States, 54703
        • Recruiting
        • Mayo Clinic Health System - Eau Claire
        • Contact:
        • Sub-Investigator:
          • Juan Pablo Domecq Garces, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of Care Group
Other: Standard of Care
Subjects will receive standard of care for sepsis treatment.
Experimental: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time alive and without vasopressor support
Time Frame: 28 days
Measured in hours
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total vasopressor requirements
Time Frame: 28 days
Measured as norepinephrine equivalents (µg)
28 days
Central venous access duration
Time Frame: 28 days
Measured in hours
28 days
Cumulative fluid balance over the first 48 hours
Time Frame: 48 hours
48 hours
Cumulative fluid balance up to 7 days of ICU stay
Time Frame: 7 days
7 days
ICU Length of Stay
Time Frame: 28 days
Total number of days admitted to the Intensive Care Unit (ICU)
28 days
Hospital Length of Stay
Time Frame: 28 days
Total number of days admitted to the hospital
28 days
ICU, hospital, and organ support-free days
Time Frame: 28 days
Number of ICU, hospital, and organ support-free days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Ognjen Gajic, MD, Mayo Clinic
  • Principal Investigator: Amos Lal, MBBS, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2024

Primary Completion (Estimated)

May 30, 2029

Study Completion (Estimated)

July 30, 2029

Study Registration Dates

First Submitted

March 13, 2024

First Submitted That Met QC Criteria

March 13, 2024

First Posted (Actual)

March 20, 2024

Study Record Updates

Last Update Posted (Actual)

August 31, 2026

Last Update Submitted That Met QC Criteria

August 27, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-000121
  • 1R61HL177037 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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