CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 100 enrolled
Drug / intervention
Guanfacine +1 moredrug
Likely dose
Guanfacine 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04578886
NCT04578886Phase 3Completed

The Effect of Guanfacine on Delirium in Critically Ill Patients

University of Alabama at Birmingham·interventional·Posted Oct 8, 2020·Updated Apr 15, 2025

In Brief

A Phase 3 clinical trial evaluating Guanfacine and Placebo for Delirium. Completed, enrolled 100 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDelirium
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedOct 8, 2020
Enrollment StartNov 23, 2020
Primary CompletionFeb 20, 2023
Study CompletionApr 1, 2023
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 5.7 years ago

Interventions

Guanfacinedrug

Guanfacine 2 mg administered at 21:00 for up to 14 days or otherwise indicated by study protocol.

Placebodrug

Placebo, administered at 2100 for up to 14 days or otherwise indicated by study protocol.