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Alpha-2 Adrenergic Agonist

Guanfacine for Neurological Dysfunction in Critical Illness (MENDING Trial)

Phase 2
Recruiting
Led By Christopher Hughes, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Requiring admission to an ICU for treatment of respiratory failure (e.g., mechanical ventilation, non-invasive positive pressure ventilation [NIPPV], Extracorporeal Membrane Oxygenation [ECMO], optiflow) and/or for treatment of shock (e.g., vasopressors, ECMO, intra-aortic balloon pump [IABP])
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

MENDING Trial Summary

This trial looks at whether a drug can improve brain function in critically ill patients.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Guanfacine may cause side effects like low blood pressure, slow heart rate, dizziness, dry mouth and fatigue. Since it's given intravenously in critically ill patients, monitoring for these effects will be part of the trial.

MENDING Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I needed intensive care for severe breathing problems or shock.

MENDING Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of days alive without delirium or coma
Secondary outcome measures
Cognition
Days alive and free of mechanical ventilation
Days alive and free of the intensive care unit
Other outcome measures
Applied Cognition
Bradycardia
Co-administration of sedatives, analgesics, and antipsychotics
+8 more

Side effects data

From 2011 Phase 4 trial • 212 Patients • NCT00429273
36%
Decreased Appetite
34%
Insomnia
33%
Headache
26%
Irritability
23%
Abdominal Pain
23%
Sedation
23%
Lethargy
21%
Somnolence
17%
Fatigue
14%
Abdominal Pain Upper
11%
Affect Lability
10%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1: Guan-Guan+Placebo
Group 2: Placebo-Placebo+DMPH
Group 3: Guan-Guan+DMPH

MENDING Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: IV GuanfacineExperimental Treatment1 Intervention
Participants will flow through the trial in the following manner: Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent Pre-randomization phase: twice daily assessments of mental status Randomize delirious patients: IV guanfacine or placebo Interventional Trial phase: study drug administration, mental status assessments, safety monitoring Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.
Group II: PlaceboPlacebo Group1 Intervention
Participants will flow through the trial in the following manner: Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent Pre-randomization phase: twice daily assessments of mental status Randomize delirious patients: IV guanfacine or placebo Interventional Trial phase: study drug administration, mental status assessments, safety monitoring Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guanfacine
2008
Completed Phase 4
~2180

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalOTHER
2,933 Previous Clinical Trials
13,198,451 Total Patients Enrolled
12 Trials studying Critical Illness
5,276 Patients Enrolled for Critical Illness
National Institute on Aging (NIA)NIH
1,672 Previous Clinical Trials
28,018,613 Total Patients Enrolled
14 Trials studying Critical Illness
6,348 Patients Enrolled for Critical Illness
Vanderbilt University Medical CenterLead Sponsor
857 Previous Clinical Trials
672,147 Total Patients Enrolled
13 Trials studying Critical Illness
5,174 Patients Enrolled for Critical Illness

Media Library

Guanfacine (Alpha-2 Adrenergic Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04742673 — Phase 2
Critical Illness Research Study Groups: Placebo, IV Guanfacine
Critical Illness Clinical Trial 2023: Guanfacine Highlights & Side Effects. Trial Name: NCT04742673 — Phase 2
Guanfacine (Alpha-2 Adrenergic Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04742673 — Phase 2

Frequently Asked Questions

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

Is there preliminary research to suggest Guanfacine's efficacy?

"There are a dozen ongoing studies investigating guanfacine, 2 of which have reached Phase 3. The majority of these trials originated from Palo Alto, California; though there are 83 total research sites for this medication."

Answered by AI

What is the most risky dosage of Guanfacine for test subjects?

"While there is some data supporting Guanfacine's safety, it received a score of 2 because there are no studies that have looked at its efficacy."

Answered by AI

For what medical reasons is Guanfacine most commonly prescribed?

"Conditions such as migraine, attention deficit hyperactivity disorder (ADHD), and hypertensive disease can all be treated effectively with Guanfacine. Additionally, this medication can also help prevent future occurrences of migraines."

Answered by AI

Are we currently enrolling patients for this trial?

"Yes, this study is still looking for participants. The information on clinicaltrials.gov shows that the first posting was on May 4th 2021 and the most recent update was January 5th 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Maximizing trEatment of Neurological Dysfunction Using INtravenous Guanfacine Study
Christopher G Hughes 2021. "Maximizing trEatment of Neurological Dysfunction Using INtravenous Guanfacine Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04742673.
~3 spots leftby Jun 2024
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