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Recruiting NCT06319248

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

Phase II Interventional Sepsis Low Blood Pressure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Midodrine, Standard of Care.
Who it may be relevant to
Registry conditions: Sepsis, Low Blood Pressure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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)
  • Other Standard of Care
    Subjects will receive standard of care for sepsis treatment.

Primary outcome measures

  • Time alive and without vasopressor support [Time frame: 28 days]
Secondary outcome measures (7)
  • Total vasopressor requirements [Time frame: 28 days]
  • Central venous access duration [Time frame: 28 days]
  • Cumulative fluid balance over the first 48 hours [Time frame: 48 hours]
  • Cumulative fluid balance up to 7 days of ICU stay [Time frame: 7 days]
  • ICU Length of Stay [Time frame: 28 days]
  • Hospital Length of Stay [Time frame: 28 days]
  • ICU, hospital, and organ support-free days [Time frame: 28 days]

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 (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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 5 centers
  • Mayo Clinic Arizona — Scottsdale
  • Mayo Clinic Florida — Jacksonville
  • Mayo Clinic Health System - Mankato — Mankato
  • Mayo Clinic Minnesota — Rochester
  • Mayo Clinic Health System - Eau Claire — Eau Claire

Publications

  • Tekin A, Halpern G, Gowda D, Bansal V, Schuchard A, Joguncic A, Schulte P, Odeyemi YE, Ahmad S, Madsen B, Rizwan Z, Barreto EF, Reddy S, Bhavsar V, Sanghavi D, Domecq Garces JP, Khan SA, Shiari A, Cartin-Ceba R, Gajic O, Lal A. Midodrine for Sepsis Treatment and Early Vasopressor Weaning (MID-STEP): protocol for a pragmatic randomised clinical trial. BMJ Open. 2026 Apr 22;16(4):e117846. doi: 10.11 PMID 42020133

Identifiers

NCT: NCT06319248 · 24-000121 · 1R61HL177037

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗