The Effect of Guanfacine on Delirium in Critically Ill Patients

• Status: Recruiting
• Trial end date: 2022-12-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Guanfacine

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

• 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

• Receiving Clonidine at time of screening

• 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