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

NCT06319248 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 24-000121
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis; Low Blood Pressure

Keywords

Vasopressors

Outcome Measures

Primary Outcomes (1)

• Time alive and without vasopressor support

  Measured in hours

  28 days

Secondary Outcomes (7)

• Total vasopressor requirements

  28 days

• Central venous access duration

  28 days

• Cumulative fluid balance over the first 48 hours

  48 hours

• Cumulative fluid balance up to 7 days of ICU stay

  7 days

• ICU Length of Stay

  28 days

Study Arms (2)

Standard of Care Group

ACTIVE COMPARATOR

Other: Standard of Care

Standard of Care with Midodrine Group

EXPERIMENTAL

Drug: Midodrine

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 with Midodrine Group

Standard of Care OTHER

Subjects will receive standard of care for sepsis treatment.

Standard of Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Sepsis; Hypotension

Interventions

Midodrine; Standard of Care

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Amos Lal, MBBS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aysun Tekin, M.D., M.S.

CONTACT

507-266-1273; Tekin.Aysun@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: May 14, 2024
• Primary Completion (Estimated): May 30, 2029
• Study Completion (Estimated): July 30, 2029
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)