MID-STEP (MIDodrine for Sepsis Treatment and Early vasoPr... | NCT06319248

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

NCT06319248

Sponsor

Mayo Clinic

Status

Recruiting

Last Update Posted

May 22, 2026Actual

Enrollment

308Estimated

Phase

Phase 2

Conditions

Sepsis
Low Blood Pressure

Interventions

Midodrine
Standard of Care

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R61HL177037	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 14, 2024Actual

Primary Completion Date

Mar 31, 2029Estimated

Completion Date

Jun 30, 2029Estimated

First Submitted Date

Mar 13, 2024

First Submission Date that Met QC Criteria

Mar 13, 2024

First Posted Date

Mar 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2026

Last Update Posted Date

May 22, 2026Actual

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

308Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard of Care Group	Active Comparator		Other: Standard of Care
Standard of Care with Midodrine Group	Experimental		Drug: Midodrine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time alive and without vasopressor support	Measured in hours	28 days

Secondary Outcomes

Measure	Description	Time Frame
Total vasopressor requirements	Measured as norepinephrine equivalents (µg)	28 days
Central venous access duration	Measured in hours

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Amy Schuchard	Contact	507-255-0148		Schuchard.Amy@mayo.edu
Aysun Tekin, MD, MS	Contact	347-421-9114		Tekin.Aysun@mayo.edu

Name	Affiliation	Role
Amos Lal, MBBS	Mayo Clinic	Principal Investigator
Ognjen Gajic, MD	Mayo Clinic	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic Arizona	Recruiting	Scottsdale	Arizona	85259	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42020133	Derived	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.

ID	Term
D018805	Sepsis
D007022	Hypotension

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals