SepsisPhase 2NCT06319248
MID-STEP (MIDodrine for Sepsis Treatment and Early vasoPressor Weaning) Trial
A Phase 2 study testing Midodrine in people with Sepsis and Low Blood Pressure, run by Mayo Clinic at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Low Blood Pressure
- What is being tested?
- Midodrine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 5 sitesUnited States
- Study dates
- 14 May 2024to 30 Jul 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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)
Show all 21Show fewer
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Mayo Clinic Health System - Eau Claire
Eau Claire, Wisconsin, 54703
Amy Schuchard, 507-255-0148, Schuchard.Amy@mayo.edu
Juan Pablo Domecq Garces, MD
- Recruiting
Mayo Clinic Florida
Jacksonville, Florida, 32224
Gabrielle Pariseau, 904-956-4079, Pariseau.Gabrielle@mayo.edu
Devang K. Sanghavi, MBBS, MD
- Recruiting
Mayo Clinic Health System - Mankato
Mankato, Minnesota, 56001
Amy Schuchard, 507-255-0148, Schuchard.Amy@mayo.edu
Amos Lal, MBBS
- Recruiting
Mayo Clinic Minnesota
Rochester, Minnesota, 55905
Amy Schuchard, 507-255-0148, Schuchard.Amy@mayo.edu
Amos Lal, MBBS
- Recruiting
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
Suraj Phull, 480-574-5993, Phull.Suraj@mayo.edu
Rodrigo Cartin-Ceba, MD
About this study
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
- Being tested
- Midodrine, Standard of Care
- Keywords
- Vasopressors
- Medical subject headings
- Sepsis, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidodrineDrug
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 CareOther
Subjects will receive standard of care for sepsis treatment.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Group | Active comparator | Not described Receives: Other: Standard of Care |
| Standard of Care with Midodrine Group | Experimental | Not described Receives: Drug: Midodrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time alive and without vasopressor support
Measured in hours
Measured: 28 days
Secondary outcomes (7)
Total vasopressor requirements
Measured as norepinephrine equivalents (µg)
Measured: 28 days
Central venous access duration
Measured in hours
Measured: 28 days
Cumulative fluid balance over the first 48 hours
Measured: 48 hours
Cumulative fluid balance up to 7 days of ICU stay
Measured: 7 days
ICU Length of Stay
Total number of days admitted to the Intensive Care Unit (ICU)
Measured: 28 days
Hospital Length of Stay
Total number of days admitted to the hospital
Measured: 28 days
ICU, hospital, and organ support-free days
Number of ICU, hospital, and organ support-free days
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start14 May 2024
- Primary completion30 May 2029 (estimated)
- Study completion30 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Ognjen Gajic, Mayo Clinic
- Investigators
- Amos Lal, MBBS, Principal investigator, Mayo ClinicOgnjen Gajic, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319248
- Sponsor's protocol ID
- 24-000121
- Other IDs
- 1R61HL177037
- Status last verified
- Aug 2026
- First submitted
- 13 Mar 2024
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MID-STEP (MIDodrine for Sepsis Treatment and Early vasoPressor Weaning) Trial
- ClinicalTrials.gov ID
- NCT06319248
- Acronym / sponsor ID
- 24-000121
- Conditions
- Sepsis, Low Blood Pressure
- Keywords
- Vasopressors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 14 May 2024 (actual)
- Primary completion
- 30 May 2029 (estimated)
- Study completion
- 30 Jul 2029 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Group | Active comparator | Other: Standard of Care |
| Standard of Care with Midodrine Group | Experimental | Drug: Midodrine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (21 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidodrineSubjects will receive standard of care for sepsis and 10 mg of Midodrine every 8 hours administered orally or enterally (via nasogastric tube) | Drug | Standard of Care with Midodrine Group |
| Standard of CareSubjects will receive standard of care for sepsis treatment. | Other | Standard of Care Group |
Primary outcome
Time alive and without vasopressor support
Time frame: 28 days
Measured in hours
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Derived from this study: PubMed 42020133Tekin 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.
- Individual participant dataSharing planned: No
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amos Lal, MBBS principal investigator
Mayo Clinic
Ognjen Gajic, MD principal investigator
Mayo Clinic
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Midodrine in people with Sepsis and Low Blood Pressure, run by Mayo Clinic at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ava Beetcher (507-255-5446, beetcher.ava@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time alive and without vasopressor support (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06319248, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.