Phase 2
N=46
Maximizing trEatment of Neurological Dysfunction Using INtravenous Guanfacine Study
Critical Illness · Delirium · Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT04742673 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Number of Days Alive Without Delirium or Coma — 7.00; 8.50 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Guanfacine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Days Alive Without Delirium or Coma |
7.00; 8.50 | — |
| SECONDARY Days Alive and Free of Mechanical Ventilation |
22.12; 19.71 | — |
| SECONDARY Days Alive and Free of the Intensive Care Unit |
19.89; 10.93 | — |
| SECONDARY Cognitive Function |
19.00; 16.00 | — |
| SECONDARY Days Alive and Free of the Hospital |
1.00; 0.00 | — |
| SECONDARY Mortality |
6; 10 | — |
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.
Eligibility Criteria
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).
- dementia or other chronic neurologic disease or disorder that makes the patient incapable of living independently at baseline
- active substance abuse, psychotic disorder, or homelessness without a secondary contact person (which would make long-term follow-up difficult)
- blindness or deafness (which would prevent assessment of the study's outcomes)
- pregnancy or breastfeeding
- prisoner
- inability to start informed consent process within 72 hours from the time that all inclusion criteria were met
- Cardiac surgery within the current hospitalization.
Data sourced from ClinicalTrials.gov (NCT04742673). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.