ClinicalTrials.gg
RecruitingNCT06319248Updated Aug 31, 2026

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

A Phase 2 interventional study of Midodrine and Standard of Care in Sepsis and Low Blood Pressure, sponsored by Mayo Clinic. Recruiting at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by Mayo Clinic · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started May 2024; still recruiting 2 years 5 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
308
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Sepsis
  • Low Blood Pressure

Keywords

  • Vasopressors
03

In context

Sepsis

2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.

This study's planned enrollment of 308 is above the median of 102 across 1,165 interventional studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
  • 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 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
308 participants (estimated)

Study arms

  • Active comparator
    Standard of Care Group

    Other: Standard of Care

  • Experimental
    Standard of Care with Midodrine Group

    Drug: Midodrine

Interventions

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

  • OtherStandard of Care

    Subjects will receive standard of care for sepsis treatment.

06

What researchers measure

Primary outcomes

  1. Time alive and without vasopressor support

    Measured in hours

    Time frame: 28 days

Secondary outcomes

  1. Total vasopressor requirements

    Measured as norepinephrine equivalents (µg)

    Time frame: 28 days

  2. Central venous access duration

    Measured in hours

    Time frame: 28 days

  3. Cumulative fluid balance over the first 48 hours

    Time frame: 48 hours

  4. Cumulative fluid balance up to 7 days of ICU stay

    Time frame: 7 days

  5. ICU Length of Stay

    Total number of days admitted to the Intensive Care Unit (ICU)

    Time frame: 28 days

  6. Hospital Length of Stay

    Total number of days admitted to the hospital

    Time frame: 28 days

  7. ICU, hospital, and organ support-free days

    Number of ICU, hospital, and organ support-free days

    Time frame: 28 days

07

Study locations

5 of 5 sites recruiting
08

References and documents

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: 10.1136/bmjopen-2026-117846. PubMed 42020133 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06319248
Lead sponsor
Mayo Clinic
Responsible party
Ognjen Gajic (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Mar 20, 2024
Start date
May 14, 2024
Primary completion
May 30, 2029 (estimated)
Completion
Jul 30, 2029 (estimated)
Last update
Aug 31, 2026

Study contacts

Ava Beetcher
Contact
beetcher.ava@mayo.edu
507-255-5446
Aysun Tekin, MD, MS
Contact
Tekin.Aysun@mayo.edu
347-421-9114
Amos Lal, MBBS
principal investigator · Mayo Clinic
Ognjen Gajic, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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