Trial Outcomes & Findings for The Effect of Guanfacine on Delirium in Critically Ill Patients (NCT NCT04578886)

Last Updated: 2025-04-15

Results Overview

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 remaining in ICU. Patients will be diagnosed as delirium free when they have four (4) negative consecutive CAM-ICU assessments.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

100 participants

Primary outcome timeframe

From the time of ICU admission up to 14 days

Results posted on

2025-04-15

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo, lactulose monohydrate, encapsulated, once nightly at 2100, for up to 14 day study duration or otherwise indicated by study protocol. Placebo: Placebo, administered at 2100 for up to 14 days or otherwise indicated by study protocol.	Guanfacine Guanfacine immediate-release, 2mg dose, over-encapsulated tablet, once nightly at 2100, for up to 14 day study duration or otherwise indicated by study protocol. Guanfacine: Guanfacine 2 mg administered at 21:00 for up to 14 days or otherwise indicated by study protocol.
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Guanfacine on Delirium in Critically Ill Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=50 Participants Placebo, lactulose monohydrate, encapsulated, once nightly at 2100, for up to 14 day study duration or otherwise indicated by study protocol. Placebo: Placebo, administered at 2100 for up to 14 days or otherwise indicated by study protocol.	Guanfacine n=50 Participants Guanfacine immediate-release, 2mg dose, over-encapsulated tablet, once nightly at 2100, for up to 14 day study duration or otherwise indicated by study protocol. Guanfacine: Guanfacine 2 mg administered at 21:00 for up to 14 days or otherwise indicated by study protocol.	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants
Age, Categorical >=65 years	29 Participants n=5 Participants	27 Participants n=7 Participants	56 Participants n=5 Participants
Age, Continuous	65.87 years STANDARD_DEVIATION 13.95 • n=5 Participants	65.36 years STANDARD_DEVIATION 12.95 • n=7 Participants	65.615 years STANDARD_DEVIATION 13.45 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	26 Participants n=7 Participants	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	14 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) White	42 Participants n=5 Participants	35 Participants n=7 Participants	77 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	50 participants n=7 Participants	100 participants n=5 Participants
Delirium Type Hypoactive Delirium	36 participants n=5 Participants	40 participants n=7 Participants	76 participants n=5 Participants
Delirium Type Hyperactive Delirium	4 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants
Delirium Type Mixed Delirium	10 participants n=5 Participants	4 participants n=7 Participants	14 participants n=5 Participants
Delirium Type Coma	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
APACHE II Score	21.6 Score on a Scale STANDARD_DEVIATION 6.4 • n=5 Participants	21.1 Score on a Scale STANDARD_DEVIATION 6.6 • n=7 Participants	21.3 Score on a Scale STANDARD_DEVIATION 6.5 • n=5 Participants

PRIMARY outcome

Timeframe: From the time of ICU admission up to 14 days

Population: Patients admitted to surgical intensive care unit at University of Alabama at Birmingham that received the study medication Guanfacine or Placebo.

Outcome measures

Outcome measures
Measure	Placebo n=50 Participants Placebo, lactulose monohydrate, encapsulated, once nightly at 2100, for up to 14 day study duration or otherwise indicated by study protocol. Placebo: Placebo, administered at 2100 for up to 14 days or otherwise indicated by study protocol.	Guanfacine n=50 Participants Guanfacine immediate-release, 2mg dose, over-encapsulated tablet, once nightly at 2100, for up to 14 day study duration or otherwise indicated by study protocol. Guanfacine: Guanfacine 2 mg administered at 21:00 for up to 14 days or otherwise indicated by study protocol.
Days Without Delirium	2.54 delirium free days Standard Deviation 3.14	3.38 delirium free days Standard Deviation 3.70

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 10 deaths

Guanfacine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 9 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Andrew B. Barker, MD

University of Alabama at Birmingham, Department of Anesthesiology and Perioperative Medicine

Phone: 205-934-6007

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place