NCT04578886

The Effect of Guanfacine on Delirium in Critically Ill Patients

Completed Phase 3 Results posted Last updated 15 April 2025

What this trial tests

Phase 3 trial testing Guanfacine in Delirium in 100 participants. Completed in 1 April 2023.

Timeline

23 November 2020

Primary endpoint
20 February 2023

1 April 2023

Quick facts

Lead sponsor	University of Alabama at Birmingham
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	100
Start date	23 November 2020
Primary completion	20 February 2023
Estimated completion	1 April 2023
Sites	1 location across United States

Drugs / interventions tested

• Guanfacine (GUANFACINE) — full drug profile →
• Placebo

Conditions studied

• Delirium — all drugs for Delirium →

Sponsor

University of Alabama at Birmingham

Who can join

18 and older, any sex, with Delirium. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Days Without Delirium Primary · From the time of ICU admission up to 14 days

The primary outcome will be the number of days alive without delirium during the 14-day treatment period after randomization. Delirium assessments are measured by the Confusion Assessment Method- Intensive Care Unit (CAM-ICU). CAM-ICU measures a patient's fluctuations in mental status, inattention, disorganized thinking, and consciousness.The CAM-ICU will be used twice daily with all patients while admitted until ICU discharge. Patients will be diagnosed as delirious when they have at least one positive CAM-ICU on the day of assessment up to ICU discharge or day 14 after enrollment if remainin

Group	Value	95% CI
Placebo	2.54	± 3.14
Guanfacine	3.38	± 3.70

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Scientific rationale for the use of α2A-adrenoceptor agonists in treating neuroinflammatory cognitive disorders.
   Arnsten AFT, Ishizawa Y, Xie Z. · · 2023 · cited 20× · PMID 37029295 · DOI 10.1038/s41380-023-02057-4
2. Scientific Rationale for the Treatment of Cognitive Deficits from Long COVID.
   Fesharaki Zadeh A, Arnsten AFT, Wang M. · · 2023 · cited 15× · PMID 37368329 · DOI 10.3390/neurolint15020045
3. The Effect of Guanfacine on Delirium in the Critically Ill: A Randomized Clinical Trial
   Barker A, Kim H, Chapleau CA, Agarwal T, et al · · 2024 · DOI 10.21203/rs.3.rs-5200341/v1