CompletedPhase 2

Maximizing trEatment of Neurological Dysfunction Using INtravenous Guanfacine Study

United States46 participantsStarted 2021-05-04

Plain-language summary

This proof-of-concept study examines whether the acute brain dysfunction that occurs in critically ill patients is improved by administration of intravenous guanfacine.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. adult patients (≥ 18 years old)
. 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 \[IABP\]).

Exclusion criteria

. allergic to guanfacine, clonidine, or dexmedetomidine
. on home antipsychotics who, therefore, require continuing antipsychotic administration in the hospital
. present history of 2nd or 3rd degree heart block, or persistent bradycardia \< 50 beats/minute that requires intervention (e.g., atropine, glycopyrrolate). If patient has a pacemaker for bradyarrythmias, then patient does not meet this exclusion criterion and may be enrolled.
. co-enrolled in another interventional trial examining similar outcomes or in a study that does not allow co-enrollment
. expected death within 24 hours of enrollment or lack of commitment to aggressive treatment by family or the medical team (e.g., likely withdrawal of life support measures within 24 hours of screening)
. acute or subacute neurologic deficit that is expected to make the patient incapable of living independently after hospital discharge due to cognitive deficits (e.g., stroke, intracranial hemorrhage, cranial trauma, intracranial malignancy, anoxic brain injury, cerebral edema).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Days Alive Without Delirium or Coma

Timeframe: 14 days after randomization

Trial details

NCT IDNCT04742673

SponsorVanderbilt University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-30

Results submitted2025-03-20

View on ClinicalTrials.gov More Critical Illness trials