Phase 3 N=100 Randomized Quadruple-blind Treatment

The Effect of Guanfacine on Delirium in Critically Ill Patients

Delirium

Bottom Line

View on ClinicalTrials.gov: NCT04578886 ↗

Enrolled (actual)

100

Serious AEs

0.0%

Results posted

Apr 2024

Primary outcome: Primary: Days Without Delirium — 2.54; 3.38 delirium free days — p=0.22

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Guanfacine (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Alabama at Birmingham
Primary completion: Feb 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Days Without Delirium	2.54; 3.38	0.22

Summary

Delirium in patients in the intensive care unit (ICU) is a common problem associated with increased mortality and morbidity, including increased hospital and ICU length of stay, greater hospital cost, increased ventilator days, and long-term cognitive disability. Various pharmacologic agents including dopamine antagonists, acetylcholinesterase inhibitors, melatonin, antipsychotics, alpha-2 agonists, and glutamate antagonists are used for treatment of delirium in the ICU despite the lack of clear evidence of efficacy.Since there is no evidence-based pharmacologic treatment of ICU delirium, current therapy is focused on non-pharmacologic prevention techniques and pharmacologic agents are used once delirium is established. Guanfacine, an alpha-2 agonist, has been identified as a potential medication that may be of benefit in the treatment of delirium. The purpose of this study to investigate the effects of guanfacine versus placebo on delirium in critically ill patients admitted to the ICU and to determine whether guanfacine along with standard of care reduces the duration of delirium, compared to standard of care alone.

Eligibility Criteria

Inclusion criteria

Patients admitted to the UAB hospital Surgical Intensive Care Unit (SICU)
18 years of age or older
Expected total ICU length of stay of 72 hours or more per treating physician
Diagnosed with delirium based on CAM-ICU assessment (see attached CAM-ICU assessment form)

Exclusion Criteria

Patients younger than 18 years old
Expected discharge from ICU within 72 hours of admission
Expected or inevitable death with 48 hours of enrollment
Pregnancy or breast feeding
Non-English speaking
Patients unable to be assessed by CAM-ICU due to neurologic illness
Altered consciousness unable to participate in CAM-ICU assessment
Patients with previous diagnosis of chronic, acute, subacute neurologic disease, or neurodegenerative disease
Mental illness and/or psychosis
Acute alcohol withdrawal
No enteral route available for administration
Treating physician refusal of enrollment based on severe hypotension (defined as requiring a vasopressor for longer than 24 hours) or bradycardia (Hr<50 bpm) at the time of screening
Hepatic encephalopathy
Blind or Hearing impaired
Taking Guanfacine, for any reason
On CYP3A inhibitor such as azole antifungals or clarithromycin
On CYP3A inducers such as phenytoin or rifampin
Severe xerostomia
Enrolled in another interventional research trial

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04578886). 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.