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

NCT ID: NCT06319248

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 308 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-14
• Study Completion Date: 2029-07-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care Group

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

Subjects will receive standard of care for sepsis treatment.

Standard of Care with Midodrine Group

Group Type: EXPERIMENTAL

Midodrine

Intervention Type: DRUG

Subjects will receive standard of care for sepsis and 10 mg of Midodrine every 8 hours administered orally or enterally (via nasogastric tube)

Interventions

Midodrine

Subjects will receive standard of care for sepsis and 10 mg of Midodrine every 8 hours administered orally or enterally (via nasogastric tube)

Intervention Type: DRUG

Standard of Care

Subjects will receive standard of care for sepsis treatment.

Intervention Type: OTHER

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 (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).
• Untreated pheochromocytoma.
• Untreated thyrotoxicosis.
• Open-angle glaucoma.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Ognjen Gajic

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amos Lal, MBBS

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic Minnesota

Rochester, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

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

Role: CONTACT

Tekin.Aysun@mayo.edu

507-266-1273

Facility Contacts

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

Role: primary

Tekin.Aysun@mayo.edu

507-266-1273

Other Identifiers

24-000121

Identifier Type: -

Identifier Source: org_study_id