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

Status: Recruiting
Location: See location...
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
Minnesota
Mayo Clinic Minnesota
RECRUITING
Rochester
Contact Information
Primary
Aysun Tekin, M.D., M.S.
Tekin.Aysun@mayo.edu
507-266-1273
Time Frame
Start Date: 2024-05-14
Estimated Completion Date: 2029-07-30
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

This content was sourced from clinicaltrials.gov