Your session is about to expire
← Back to Search
Vasopressor
Midodrine for Vasoplegic Syndrome
Phase 4
Recruiting
Led By Oleksa Rewa, MD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age > 18 years
Ongoing vasopressor support
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will test whether midodrine can help reduce the need for IV vasopressors to raise blood pressure in ICU patients.
Who is the study for?
This trial is for adults over 18 in the ICU needing lower doses of IV blood pressure meds. They can't have taken midodrine recently, be pregnant, allergic to midodrine, or expected to pass away or stop life support within a day.Check my eligibility
What is being tested?
The study tests if midodrine, an oral medication, can help wean patients off IV blood pressure drugs faster in the ICU compared to a placebo (a pill with no active drug).See study design
What are the potential side effects?
Midodrine may cause side effects like tingling scalp sensations, chills goosebumps, urinary urgency and problems with urination.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
Select...
I am currently on medication to raise my blood pressure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
ICU length of stay
Secondary outcome measures
Cost effectiveness
Duration of vasopressor support
Hospital costs
+6 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)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MidodrineExperimental Treatment1 Intervention
Midodrine 10 mg PO/NG q8h
Group II: PlaceboPlacebo Group1 Intervention
Microcrystalline cellulose PO/NG q8h
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Midodrine
FDA approved
Find a Location
Who is running the clinical trial?
University of AlbertaLead Sponsor
889 Previous Clinical Trials
384,788 Total Patients Enrolled
Institute of Health Economics, CanadaOTHER
8 Previous Clinical Trials
2,953 Total Patients Enrolled
University Hospital FoundationOTHER
7 Previous Clinical Trials
1,036 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to midodrine.I cannot take medications by mouth due to a medical condition.It has been over 24 hours since my highest dose of medication to raise blood pressure.I am on a lower dose of medication to raise my blood pressure.I am older than 18 years.It is expected that the participant will pass away or stop life-sustaining treatments within the next 24 hours.I have taken midodrine in the last week.I am currently on medication to raise my blood pressure.
Research Study Groups:
This trial has the following groups:- Group 1: Midodrine
- Group 2: Placebo
Awards:
This trial has 4 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are enrolled in this research project?
"Affirmative. Clinicaltrials.gov data confirms that the trial, posted on March 22nd 2021 and updated October 24th 2022 is currently recruiting 350 participants at one medical site."
Answered by AI
Is the research team actively seeking volunteers for this experiment?
"Based on the most recent post by clinicaltrials.gov, this research is actively accepting new patients since March 22nd 2021 and was last updated October 24th 2022."
Answered by AI
Has the Federal Drug Administration given its seal of approval to Midodrine?
"Our analysts at Power have rated midodrine's safety with a score of 3, given that the drug has been approved by regulatory bodies and is in phase 4 trials."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger