MID-STEP (MIDodrine for Sepsis Treatment and Early vasoPressor Weaning) Trial
Part of paid clinical trials in Scottsdale, Arizona.
- Sponsor
- Mayo Clinic
- Study ID
- NCT06319248
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Low Blood Pressure
- Sepsis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Midodrine — DRUGSubjects 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 — OTHERSubjects will receive standard of care for sepsis treatment.
Study Details
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.
Key Dates
- Start date
- May 14, 2024
- Status verified
- May 2026
- Primary completion
- Mar 31, 2029
- Completion
- Jun 30, 2029
Study Design
- Enrollment
- 308 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Standard of Care Group
- Experimental: Standard of Care with Midodrine Group
Primary Outcome Measure
Time alive and without vasopressor support [ Time Frame: 28 days ]
Central Contacts
- Amy Schuchard507-255-0148
- Aysun Tekin, MD, MS347-421-9114
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic Arizona | Scottsdale | Arizona | 85259 | Rodrigo Cartin-Ceba, MD (SUB_INVESTIGATOR) |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | Devang K. Sanghavi, MBBS, MD (SUB_INVESTIGATOR) |
| Mayo Clinic Health System - Mankato | Mankato | Minnesota | 56001 | Amos Lal, MBBS (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic Minnesota | Rochester | Minnesota | 55905 | Amos Lal, MBBS (PRINCIPAL_INVESTIGATOR) Ognjen Gajic, MD (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic Health System - Eau Claire | Eau Claire | Wisconsin | 54703 | Juan Pablo Domecq Garces, MD (SUB_INVESTIGATOR) |
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