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Vasopressor

Standard of Care with Midodrine Group for Sepsis

Phase 2 & 3

Waitlist Available

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 48 hours

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 ~ 48 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time alive and without vasopressor support

Secondary outcome measures

Central venous access duration

Cumulative fluid balance over the first 48 hours

Cumulative fluid balance up to 7 days of ICU stay

+4 more

Side effects data

From 2012 Phase 4 trial • 29 Patients • NCT00108355

GI Bleeding

Hepatic encephalopathy

Scrotal edema

100%

80%

60%

40%

20%

Study treatment Arm

Albumin (Control Group)

Vasoconstrictor (Treatment Group)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

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 Group with PlaceboPlacebo Group1 Intervention

Subjects will receive standard of care for sepsis and three doses of placebo every 8 hours .

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Midodrine

2008

Completed Phase 4

~1160

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,220 Previous Clinical Trials

3,767,681 Total Patients Enrolled

14 Trials studying Sepsis

19,127 Patients Enrolled for Sepsis

Amos Lal, MBBSPrincipal InvestigatorMayo Clinic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for potential participants in this research study?

"The current information from clinicaltrials.gov indicates that this particular study is not presently seeking participants. The trial was initially posted on March 30, 2024, with the most recent update made on March 13, 2024. Despite its inactivity in recruiting subjects currently, there are approximately 314 alternative trials actively looking for candidates to participate."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Use of Midodrine in Septic Shock Patients

Amos Lal 2024. "Use of Midodrine in Septic Shock Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06319248.

All > Sepsis