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Vasopressor
Midodrine for Sepsis
Phase 2 & 3
Recruiting
Led By Amos Lal, MBBS
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if giving Midodrine early can help people with sepsis need less medication to maintain their blood pressure. If successful, this could lead to shorter hospital stays, less time
Who is the study for?
This trial is for individuals with sepsis and low blood pressure who may benefit from an alternative to intravenous medications. Specific eligibility criteria are not provided, but typically participants would need to meet certain health conditions.
What is being tested?
The study tests if Midodrine, taken early on, can help maintain higher blood pressure in septic shock patients without needing IV meds. It's compared against a placebo to see if it reduces the need for vasopressors.
What are the potential side effects?
While specific side effects of Midodrine in this context aren't listed, generally it can cause tingling scalp sensations, chills or goosebumps, urinary urgency or problems with urination due to its action on blood vessels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Time alive and without vasopressor support
Secondary study objectives
Central venous access duration
Hospital Length of Stay
ICU Length of Stay
+2 moreSide effects data
From 2012 Phase 4 trial • 29 Patients • NCT001083558%
GI Bleeding
8%
Hepatic encephalopathy
8%
Scrotal edema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Albumin (Control Group)
Vasoconstrictor (Treatment Group)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of Care with Midodrine GroupExperimental Treatment1 Intervention
Subjects will receive standard of care for sepsis and three doses of midodrine every 8 hours.
Group II: Standard of Care GroupActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Midodrine
2008
Completed Phase 4
~1160
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,337 Previous Clinical Trials
3,060,904 Total Patients Enrolled
Amos Lal, MBBSPrincipal InvestigatorMayo Clinic
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