Guanfacine for Neurological Dysfunction in Critical Illness
(MENDING Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether guanfacine, administered intravenously, can improve brain function in critically ill patients. The focus is on those in the ICU for severe conditions such as breathing problems or shock. Participants will receive either guanfacine or a placebo to determine its effect on mental status. Ideal candidates are those in the ICU requiring intensive breathing support or treatment for shock. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are on antipsychotics at home and need to continue them in the hospital, you cannot participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that guanfacine is generally safe for people and is well-tolerated by both very sick patients and children with ADHD. One study found that guanfacine helped reduce confusion and the need for sedative drugs in hospitalized patients. Another review concluded that guanfacine is a safe and well-tolerated medication for individuals with various types of hyperactivity. Overall, the safety data for guanfacine is reassuring, with no major side effects reported in these studies.12345
Why do researchers think this study treatment might be promising?
Most treatments for neurological dysfunction in critical illness focus on managing symptoms with sedatives or antipsychotics. However, Guanfacine offers a fresh approach by acting on alpha-2 adrenergic receptors in the brain, potentially calming hyperactive neurological responses. Researchers are excited because this mechanism could address the root of cognitive disturbances, like delirium, rather than just the symptoms. Additionally, Guanfacine's use in an intravenous form allows for precise dosing in critically ill patients, which could lead to more immediate and controlled effects compared to oral medications. This unique approach may provide quicker, more effective relief for patients experiencing severe neurological dysfunction in the ICU.
What evidence suggests that guanfacine might be an effective treatment for acute brain dysfunction in critically ill patients?
Research has shown that guanfacine might help with sudden brain problems in very sick patients. In this trial, participants will receive either IV guanfacine or a placebo. One study found that guanfacine reduced the severity of confusion (delirium) and decreased the need for calming medications in hospitalized patients. Other studies indicate that guanfacine is safe for both very sick adults and children with ADHD. Overall, these findings suggest that guanfacine could be useful for managing brain issues in critical care settings.12346
Who Is on the Research Team?
Christopher G Hughes, MD
Principal Investigator
Vanderbilt University Medical Center
Are You a Good Fit for This Trial?
Adults over 18 needing ICU care for respiratory failure or shock can join this trial. Excluded are prisoners, those with sensory impairments preventing outcome assessment, expected death within 24 hours, pregnant/breastfeeding women, certain heart conditions, allergies to study drugs, on home antipsychotics or with cognitive deficits making independent living impossible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-randomization
Twice daily assessments of mental status before randomization
Interventional Trial
Study drug administration, mental status assessments, safety monitoring, and blood draws
Follow-up
Participants are monitored for safety and effectiveness after treatment with telephone and online questionnaires
What Are the Treatments Tested in This Trial?
Interventions
- Guanfacine
- Placebo
Trial Overview
The study is testing if intravenous guanfacine can improve brain dysfunction in critically ill patients. Participants will either receive guanfacine or a placebo to see which is more effective at treating delirium and cognitive impairment during critical illness.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.
Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor
Massachusetts General Hospital
Collaborator
National Institute on Aging (NIA)
Collaborator
Citations
Guanfacine for Neurological Dysfunction in Critical Illness
Guanfacine is generally considered safe for humans, with studies showing it is well-tolerated in both critically ill patients and children with ADHD.
Efficacy and safety of guanfacine in hospitalized patients ...
Guanfacine therapy was associated with delirium attenuation and a reduction in the use of sedative agents. Median dosage was 1.5 mg daily.
A Retrospective Analysis of Guanfacine for ... - PubMed Central
Based on our retrospective study, guanfacine is a well-tolerated medication for the management of delirium. Even in medically and critically ill ...
Study Results | Maximizing trEatment of Neurological ...
A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved ...
5.
ctv.veeva.com
ctv.veeva.com/study/maximizing-treatment-of-neurological-dysfunction-using-intravenous-guanfacine-studyMaximizing trEatment of Neurological Dysfunction Using ...
This proof-of-concept study examines whether the acute brain dysfunction that occurs in critically ill patients is improved by administration of ...
6.
adhdevidence.org
adhdevidence.org/blog/safety-and-efficacy-of-long-term-use-of-guanfacine-for-adults-with-adhdSafety and efficacy of long-term use of guanfacine for ...
A Japanese research team set out to explore the long-term administration of once-daily GXR in adults with ADHD over a year of treatment.
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