Recruiting
Phase 2

Midodrine

Sponsor:

Mayo Clinic

Code:

NCT06319248

Conditions

Sepsis

Low Blood Pressure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Midodrine

Standard of Care

Study Details

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 ID

NCT06319248

Start date

May 14, 2024

Status verified date

Aug, 2026

Completion date

Jul 30, 2029

Anticipated

Primary completion date

May 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

308 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard of Care Group

experimental: Standard of Care with Midodrine Group

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)

Standard of Care

Subjects will receive standard of care for sepsis treatment.

Primary outcome measure

  • Time alive and without vasopressor support [ Time Frame: 28 days ]

Central Contacts and Locations

Central contacts

Ava Beetcher

507-255-5446beetcher.ava@mayo.edu

Aysun Tekin, MD, MS

347-421-9114Tekin.Aysun@mayo.edu

Locations

Mayo Clinic Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Suraj Phull

480-574-5993Phull.Suraj@mayo.edu

Mayo Clinic Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Gabrielle Pariseau

904-956-4079Pariseau.Gabrielle@mayo.edu

Mayo Clinic Health System - Mankato

Recruiting

Mankato, Minnesota, United States, 56001

Contacts

Amy Schuchard

507-255-0148Schuchard.Amy@mayo.edu

Principal Investigator:

Amos Lal, MBBS

Mayo Clinic Minnesota

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Amy Schuchard

507-255-0148Schuchard.Amy@mayo.edu

Principal Investigator:

Amos Lal, MBBS

Mayo Clinic Health System - Eau Claire

Recruiting

Eau Claire, Wisconsin, United States, 54703

Contacts

Amy Schuchard

507-255-0148Schuchard.Amy@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Keywords

  • Vasopressors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-31.