Sepsis Clinical Trials

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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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).

Locations
United States
Arizona
Mayo Clinic Arizona
RECRUITING
Scottsdale
Florida
Mayo Clinic Florida
RECRUITING
Jacksonville
Minnesota
Mayo Clinic Health System - Mankato
RECRUITING
Mankato
Mayo Clinic Minnesota
RECRUITING
Rochester
Wisconsin
Mayo Clinic Health System - Eau Claire
RECRUITING
Eau Claire
Contact Information
Primary
Amy Schuchard
Schuchard.Amy@mayo.edu
507-255-0148
Backup
Aysun Tekin, MD, MS
Tekin.Aysun@mayo.edu
347-421-9114
Time Frame
Start Date: 2024-05-14
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 308
Treatments
Active_comparator: Standard of Care Group
Experimental: Standard of Care with Midodrine Group
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov