270 Participants Needed
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Midodrine for Sepsis

Recruiting in Rochester (>99 mi)
AT
Overseen ByAysun Tekin, M.D., M.S.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot participate if you are currently using monoamine oxidase inhibitors or fludrocortisone acetate. If you are on these medications, you would need to stop them to join the trial.

Is Midodrine generally safe for human use?

There is no relevant safety information about Midodrine in the provided research articles.12345

How does the drug Midodrine differ from other treatments for sepsis?

Midodrine is unique in treating sepsis because it is primarily used to increase blood pressure by constricting blood vessels, which can be crucial in managing the low blood pressure often seen in sepsis. Unlike other treatments that may focus on infection control or organ support, Midodrine specifically targets the vascular system to stabilize blood pressure.24678

Who Is on the Research Team?

AL

Amos Lal, MBBS

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I was diagnosed with sepsis within a day of meeting the specific criteria for it.
I was admitted to the hospital for a suspected infection and my organ function has worsened.
I have low blood pressure despite receiving fluids in the ED or ICU.

Exclusion Criteria

I cannot consent for myself and have no one to consent for me.
I have had a stroke in the last 3 months.
I have been treated for peripheral vascular disease in the last 3 months.
See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive standard care for sepsis and three doses of midodrine every 8 hours

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Midodrine
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of Care with Midodrine GroupExperimental Treatment1 Intervention
Group II: Standard of Care GroupActive Control1 Intervention

Midodrine is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as ProAmatine for:
🇪🇺
Approved in European Union as Orvaten for:

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Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Published Research Related to This Trial

Dimebon (latrepirdine) shows potential as a therapeutic agent for neurodegenerative diseases by improving cellular energy balance and stabilizing mitochondrial function, which is crucial for brain health.
In preclinical models, Dimebon treatment reduced harmful protein aggregates and activated autophagy, suggesting it may modify disease progression, especially when administered early in the disease onset.
Novel Sites of Neuroprotective Action of Dimebon (Latrepirdine).Ustyugov, A., Shevtsova, E., Bachurin, S.[2020]
Structural modifications of oxotremorine and its acetamide analogue revealed that increasing the size of quaternary ammonium groups reduces their muscarinic potency, indicating a clear relationship between molecular structure and activity.
Tertiary amines showed a decrease in muscarinic activity due to loss of efficacy, with higher homologues acting as partial agonists or antagonists, suggesting that the design of these compounds can influence their therapeutic potential.
Muscarinic activity of some secondary and tertiary amines and quaternary ammonium salts structurally related to oxotremorine.Resul, B., Ringdahl, B., Dahlbom, R., et al.[2019]
Dimebon, originally an anti-histamine, shows potential as a treatment for Alzheimer's and Huntington's diseases due to its high affinity for multiple receptors, including serotonergic, alpha-adrenergic, and dopaminergic receptors, suggesting a complex mechanism of action.
The drug's ability to inhibit butyrylcholinesterase and interact with various histamine receptors indicates a pharmacological basis for its re-purposing, which could lead to more effective multi-target therapies for these neurodegenerative diseases.
From anti-allergic to anti-Alzheimer's: Molecular pharmacology of Dimebon.Okun, I., Tkachenko, SE., Khvat, A., et al.[2019]

Citations

Novel Sites of Neuroprotective Action of Dimebon (Latrepirdine). [2020]
Muscarinic activity of some secondary and tertiary amines and quaternary ammonium salts structurally related to oxotremorine. [2019]
3.United Arab Emiratespubmed.ncbi.nlm.nih.gov
From anti-allergic to anti-Alzheimer's: Molecular pharmacology of Dimebon. [2019]
Central and peripheral mediation of hypothermia, tremor and salivation induced by muscarinic agonists in mice. [2019]
Safety and tolerability of CI-979 in patients with Alzheimer's disease. [2019]
Fluoroethylnormemantine (FENM) shows synergistic protection in combination with a sigma-1 receptor agonist in a mouse model of Alzheimer's disease. [2023]
Memory improvement without toxicity during chronic, low dose intravenous arecoline in Alzheimer's disease. [2019]
8.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[2-Amino-2-thiazoline derivatives--a novel chemotype possessing muscarinomimetic effect]. [2017]
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