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 — 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 — OTHER
    Subjects 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

Locations (5)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaScottsdaleArizona85259
Suraj Phull
480-574-5993
Rodrigo Cartin-Ceba, MD (SUB_INVESTIGATOR)
Mayo Clinic FloridaJacksonvilleFlorida32224
Gabrielle Pariseau
904-956-4079
Devang K. Sanghavi, MBBS, MD (SUB_INVESTIGATOR)
Mayo Clinic Health System - MankatoMankatoMinnesota56001
Amy Schuchard
507-255-0148
Amos Lal, MBBS (PRINCIPAL_INVESTIGATOR)
Mayo Clinic MinnesotaRochesterMinnesota55905
Amy Schuchard
507-255-0148
Amos Lal, MBBS (PRINCIPAL_INVESTIGATOR)
Ognjen Gajic, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Health System - Eau ClaireEau ClaireWisconsin54703
Amy Schuchard
507-255-0148
Juan Pablo Domecq Garces, MD (SUB_INVESTIGATOR)

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