Trial Outcomes & Findings for The Effect of Guanfacine on Delirium in Critically Ill Patients (NCT NCT04578886)
NCT ID: 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.
COMPLETED
PHASE3
100 participants
From the time of ICU admission up to 14 days
2025-04-15
Participant Flow
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
| 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=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
29 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Age, Continuous
|
65.87 years
STANDARD_DEVIATION 13.95 • n=99 Participants
|
65.36 years
STANDARD_DEVIATION 12.95 • n=107 Participants
|
65.615 years
STANDARD_DEVIATION 13.45 • n=206 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=99 Participants
|
50 participants
n=107 Participants
|
100 participants
n=206 Participants
|
|
Delirium Type
Hypoactive Delirium
|
36 participants
n=99 Participants
|
40 participants
n=107 Participants
|
76 participants
n=206 Participants
|
|
Delirium Type
Hyperactive Delirium
|
4 participants
n=99 Participants
|
5 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Delirium Type
Mixed Delirium
|
10 participants
n=99 Participants
|
4 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Delirium Type
Coma
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
APACHE II Score
|
21.6 Score on a Scale
STANDARD_DEVIATION 6.4 • n=99 Participants
|
21.1 Score on a Scale
STANDARD_DEVIATION 6.6 • n=107 Participants
|
21.3 Score on a Scale
STANDARD_DEVIATION 6.5 • n=206 Participants
|
PRIMARY outcome
Timeframe: From the time of ICU admission up to 14 daysPopulation: Patients admitted to surgical intensive care unit at University of Alabama at Birmingham that received the study medication Guanfacine or Placebo.
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.
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
Guanfacine
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place