Trial · NCT04578886
The Effect of Guanfacine on Delirium in Critically Ill Patients
NCT04578886, Phase 3, Completed, University of Alabama at Birmingham; results first posted 2024-04-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Effect of Guanfacine on Delirium in Critically Ill Patients. Trials, record NCT04578886. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04578886
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effect of Guanfacine on Delirium in Critically Ill Patients
- NCT number
- NCT04578886
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 100 participants, actual
- Lead sponsor
- University of Alabama at Birmingham
- Conditions
- Delirium
- Interventions
- Guanfacine, Placebo
- First posted
- 2020-10-08
- Last updated
- 2025-04-15
- Results first posted
- 2024-04-17
- Limitations and caveats
This study is limited by the nature of being a single center design with a small sample size. The study population is in the critically ill surgical patient and this acuity and demographic may limit the external validity.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Days Without Delirium | 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 remaining in ICU. Patients will be diagnosed as delirium free when they have four (4) negative consecutive CAM-ICU assessments. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Days Without Delirium | From the time of ICU admission up to 14 days | Patients admitted to surgical intensive care unit at University of Alabama at Birmingham that received the study medication Guanfacine or Placebo. | delirium free days | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Days Without Delirium | Placebo | 2.54 | Standard Deviation 3.14 | delirium free days | |
| Days Without Delirium | Guanfacine | 3.38 | Standard Deviation 3.70 | delirium free days |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 50 | |
| Overall Study | STARTED | Guanfacine | 50 | |
| Overall Study | COMPLETED | Placebo | 50 | |
| Overall Study | COMPLETED | Guanfacine | 50 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Guanfacine | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 10 | 50 |
| Total, all-cause mortality | Guanfacine | 9 | 50 |
| Total, other adverse events | Placebo | 0 | 50 |
| Total, other adverse events | Guanfacine | 0 | 50 |
| Total, serious adverse events | Placebo | 0 | 50 |
| Total, serious adverse events | Guanfacine | 0 | 50 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37029295 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Guanfacine vs Placebo: deaths from any cause | Trial comparisons |
| Guanfacine vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04578886
GET https://conductscience.org/api/trials/v1/NCT04578886/registered