Trial Outcomes & Findings for Maximizing trEatment of Neurological Dysfunction Using INtravenous Guanfacine Study (NCT NCT04742673)

NCT ID: NCT04742673

Last Updated: 2026-02-05

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 46 participants
• Primary outcome timeframe: 14 days after randomization
• Results posted on: 2026-02-05

Participant Flow

Participant milestones

Measure	Placebo Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.	IV Guanfacine Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.
Overall Study STARTED	23	23
Overall Study COMPLETED	19	20
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Measure	Placebo Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.	IV Guanfacine Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.
Overall Study Did not receive any study drug and not included in assessments or results	4	3

Baseline Characteristics

Maximizing trEatment of Neurological Dysfunction Using INtravenous Guanfacine Study

Baseline characteristics by cohort

Measure	Placebo n=19 Participants Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.	IV Guanfacine n=20 Participants Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.	Total n=78 Participants Total of all reporting groups
Age, Continuous	65.5 years n=19 Participants	60.5 years n=20 Participants	62.3 years n=39 Participants
Sex: Female, Male Female	9 Participants n=19 Participants	9 Participants n=20 Participants	18 Participants n=39 Participants
Sex: Female, Male Male	10 Participants n=19 Participants	11 Participants n=20 Participants	21 Participants n=39 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=19 Participants	0 Participants n=20 Participants	1 Participants n=39 Participants
Race (NIH/OMB) Asian	0 Participants n=19 Participants	0 Participants n=20 Participants	0 Participants n=39 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=19 Participants	0 Participants n=20 Participants	0 Participants n=39 Participants
Race (NIH/OMB) Black or African American	4 Participants n=19 Participants	0 Participants n=20 Participants	4 Participants n=39 Participants
Race (NIH/OMB) White	14 Participants n=19 Participants	20 Participants n=20 Participants	34 Participants n=39 Participants
Race (NIH/OMB) More than one race	0 Participants n=19 Participants	0 Participants n=20 Participants	0 Participants n=39 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=19 Participants	0 Participants n=20 Participants	0 Participants n=39 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=19 Participants	1 Participants n=20 Participants	1 Participants n=39 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=19 Participants	19 Participants n=20 Participants	38 Participants n=39 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=19 Participants	0 Participants n=20 Participants	0 Participants n=39 Participants
SOFA score at ICU admission	10 SOFA score n=19 Participants	13.5 SOFA score n=20 Participants	13 SOFA score n=39 Participants

PRIMARY outcome

Timeframe: 14 days after randomization

Outcome measures

Measure	Placebo n=19 Participants Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.	IV Guanfacine n=20 Participants Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.
Number of Days Alive Without Delirium or Coma	7.00 days Interval 2.0 to 10.5	8.50 days Interval 1.75 to 10.0

SECONDARY outcome

Timeframe: 28 days after randomization

Outcome measures

Measure	Placebo n=19 Participants Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.	IV Guanfacine n=20 Participants Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.
Days Alive and Free of Mechanical Ventilation	22.12 days Interval 4.18 to 26.9	19.71 days Interval 4.45 to 27.0

SECONDARY outcome

Timeframe: 28 days after randomization

Outcome measures

Measure	Placebo n=19 Participants Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.	IV Guanfacine n=20 Participants Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.
Days Alive and Free of the Intensive Care Unit	19.89 days Interval 1.25 to 23.99	10.93 days Interval 0.0 to 23.01

SECONDARY outcome

Timeframe: 180 days after randomization

Telephone Montreal Cognitive Assessment has a minimum score of 0 and a maximum score of 22, with higher numbers indicating better cognition. A score of 18 or below is considered a positive screen for at least mild cognitive impairment.

Outcome measures

Measure	Placebo n=10 Participants Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.	IV Guanfacine n=3 Participants Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.
Cognitive Function	19.00 Units on a scale Interval 18.5 to 20.5	16.00 Units on a scale Interval 15.0 to 16.5

SECONDARY outcome

Timeframe: 28 days after randomization

Outcome measures

Measure	Placebo n=19 Participants Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.	IV Guanfacine n=20 Participants Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.
Days Alive and Free of the Hospital	1.00 days Interval 0.0 to 7.93	0.00 days Interval 0.0 to 1.24

SECONDARY outcome

Timeframe: 90 days after randomization

Outcome measures

Measure	Placebo n=19 Participants Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.	IV Guanfacine n=20 Participants Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.
Mortality	6 Participants	10 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 180 days after after randomization

Patient-Reported Outcomes Measurement Information System V.1.2-Physical Function 8b is a process that involves using a specific set of 8 questions to assess a patient's self-reported ability to perform physical activities. These questions are designed to measure a person's physical function, focusing on their ability to perform daily activities, including those involving upper and lower extremities, and central body regions. Patients respond to each question on a scale, typically a five-point scale (e.g., 1 = not at all to 5 = completely). The total raw score is then converted to a T-score using a table provided in the PROMIS scoring manual. T-scores are standardized scores with a mean of 50 and a standard deviation of 10, allowing for comparison across individuals and populations. Higher T-scores generally indicate a higher level of physical function.

Outcome measures

Measure	Placebo n=10 Participants Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.	IV Guanfacine n=3 Participants Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.
Physical Function	31.9 Units on a scale Interval 27.8 to 39.4	36.4 Units on a scale Interval 35.9 to 36.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 180 days after after randomization

Patient-Reported Outcomes Measurement Information System V.1.1-Global is a 10-item questionnaire that measures physical and mental health in patients. The questionnaire uses a T-score metric, where a score of 50 represents the average for the US population with a standard deviation of 10. Higher T-scores indicate better health.

Outcome measures

Measure	Placebo n=10 Participants Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.	IV Guanfacine n=3 Participants Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.
Global Health	37.4 T-score Interval 30.9 to 42.3	36.1 T-score Interval 34.2 to 37.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 180 days after randomization

Patient-Reported Outcomes Measurement Information System V.1.0-Pain Interference 8a measures the self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. It consists of 8 questions, each with a scale ranging from 1 (Not at all) to 5 (Very much). The score is calculated by summing the responses to all 8 questions, resulting in a raw score range from 8 to 40. This raw score is then converted into a T-score, with a mean of 50 and a standard deviation of 10, and a higher T-score indicating more pain interference.

Outcome measures

Measure	Placebo n=10 Participants Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.	IV Guanfacine n=3 Participants Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.
Pain Interference	59.1 Units on a scale Interval 55.2 to 67.5	60.5 Units on a scale Interval 57.3 to 63.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 180 days after randomization

Patient-Reported Outcomes Measurement Information System V.1.0-Applied Cognition is designed to assess a patient's self-perceived cognitive abilities and concerns in everyday life. The PROMIS measures use a T-score metric with a mean of 50 and a standard deviation of 10, where higher scores indicate better perceived cognitive functioning.

Outcome measures

Measure	Placebo n=10 Participants Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.	IV Guanfacine n=3 Participants Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.
Applied Cognition	47.7 Units on a scale Interval 42.5 to 53.5	49.6 Units on a scale Interval 47.0 to 52.3

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 180 days after hospital discharge

Patient-Reported Outcomes Measurement Information System V.1.0-Sleep Disturbance utilizes a 5-point Likert scale to assess sleep quality, with higher scores indicating greater sleep disturbance. The scale's T-score is a standardized score with a mean of 50 and a standard deviation of 10, with higher scores indicating a greater level of sleep disturbance.

Outcome measures

Measure	Placebo n=10 Participants Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.	IV Guanfacine n=3 Participants Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.
Sleep	57.0 Units on a scale Interval 48.7 to 64.4	52.8 Units on a scale Interval 48.3 to 57.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 14 days after randomization

Total opioid dose in fentanyl equivalents

Outcome measures

Measure	Placebo n=19 Participants Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.	IV Guanfacine n=20 Participants Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.
Co-administration of Analgesics	4369 mcg Interval 1926.0 to 8229.0	1883 mcg Interval 638.0 to 4255.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 14 days after randomization, while on study drug

Refractory systolic blood pressure < 90 mm Hg or Mean arterial blood pressure < 65 mm Hg despite ongoing ICU therapies

Outcome measures

Measure	Placebo n=19 Participants Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.	IV Guanfacine n=20 Participants Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.
Hypotension	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 14 days after randomization, while on study drug

Heart rate < 60 beats per minute despite ongoing ICU therapies

Outcome measures

Measure	Placebo n=19 Participants Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.	IV Guanfacine n=20 Participants Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.
Bradycardia	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 14 days after randomization, while on study drug

New, acute neurologic disturbances such as blurred vision, dizziness, weakness, or vertigo

Outcome measures

Measure	Placebo n=19 Participants Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.	IV Guanfacine n=20 Participants Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge.
Mental Status	0 Participants	0 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 6 deaths

IV Guanfacine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 10 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=19 participants at risk Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge. Placebo: Patients randomized to the placebo arm will receive intravenous normal saline when they exhibit ICU delirium.	IV Guanfacine n=20 participants at risk Participants will flow through the trial in the following manner: 1. Consent in ICU: perform required inclusion/exclusion assessments; discuss study goals, activities, and requirements; obtain informed consent 2. Pre-randomization phase: twice daily assessments of mental status 3. Randomize delirious patients: IV guanfacine or placebo 4. Interventional Trial phase: study drug administration, mental status assessments, safety monitoring 5. Blood draws: collect blood samples on Interventional Trial Phase days 1 and 2 6. Follow-up assessments: telephone and online questionnaires at 30, 90, and 180 days after hospital discharge. Guanfacine: Patients randomized to the IV Guanfacine arm will receive intravenous guanfacine when they exhibit ICU delirium.
Injury, poisoning and procedural complications Fall	0.00% 0/19 • 180 days from randomization	5.0% 1/20 • Number of events 1 • 180 days from randomization

Additional Information

Christopher Hughes

Vanderbilt University Medical Center

Phone: 615-322-5000

Email: christopher.hughes@vumc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place