A Phase 4 interventional study of Clonidine and Placebo in Delirium, sponsored by Memorial Health University Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-14.
Sponsored by Memorial Health University Medical Center · Phase 4, Interventional, and Treatment
This study will attempt to learn how to better treat trauma patients with delirium who are on a breathing machine. Delirium, also known as acute, temporary brain dysfunction, is a common reason why ventilated patients can not be weaned from the breathing machine even though their lungs may be healthy enough to breathe without the machine. The study hopes to show that by decreasing the patient's delirium it will lead to quicker weaning from the breathing machine and possibly a quicker overall recovery as well. Patients enrolled in this study will be treated with Clonidine or placebo. Clonidine is a drug that produces significant calming effects, decreases anxiety, and reduces pain, but with a lower incidence of delirium than other medications used in the ICU for this purpose. Clonidine is not approved by the Federal Food and Drug Administration for treatment of delirium, but is commonly used for this purpose.
Obtaining the appropriate level of sedation and analgesia in severely injured trauma patients admitted to the intensive care unit (ICU) can be challenging due to the diversity of injuries as well as the breadth of comorbidities present in this population. Clonidine may be a useful adjuvant to traditional analgesics such as opioids and sedatives such as benzodiazepines and propofol. Ventilator dependent trauma patients frequently fail extubation trials secondary to inappropriate sedation, inadequate analgesia or undertreated delirium. Patients that fail extubation for these reasons have a potentially preventable prolonged ventilator, ICU and hospital course. Ventilated trauma patients that meet criteria for our institution's SBT protocol and have the diagnosis of delirium will be considered for the trial if they have a documented failed SBT. We hypothesize treatment of this patient population with transdermal Clonidine will decrease delirium in trauma patients during their ICU stay. Patients enrolled in the treatment group will receive an oral loading dose of Clonidine 0.3 mg and placement of a Clonidine Transdermal system at a dose of 0.3-mg/day (Catapres TTS-3) covered by a patch overlay. In 12 hours the patient will receive a second and final dose of Clonidine 0.3 mg. The placebo group will receive a placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final placebo tablet. A total of 120 patients will be enrolled, 60 patients in each group. All patients will complete the study at end of Day 14 or upon discharge from the hospital, whichever comes sooner. Ventilator times will be measured in each group as well as the prevalence of delirium by the amount of positive CAM-ICU scores over the course of the trial.
1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.
This study's enrollment of 22 is below the median of 120 across 599 interventional studies indexed under Delirium.
Browse Delirium studies →Memorial Health University Medical Center is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
An oral loading dose of Clonidine 0.3 mg and placement of a Clonidine Transdermal system at a dose of 0.3 mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3 mg after 12 hours
Drug: Clonidine
Placebo group will receive a placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final placebo tablet
Drug: Placebo
An oral loading dose of Clonidine 0.3 mg and placement of Clonidine Transdermal system at a dose of 0.3-mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3mg after 12 hours
A placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final tablet
Duration of Mechanical Ventilation Following Administration of the First Dose of Clonidine or Placebo
data were not collected
Time frame: 2 or more years
Incidence and Duration in Hours of Delirium Currently Used
As assessed by the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) score Data were not collected
Time frame: 2 or more years
Time to Pass First SBT Following Administration of the First Dose of Clonidine or Placebo
Hours. data were not collected
Time frame: 2 or more years
Mean Incidence and Duration of Delirium
As assessed by daily CAM score currently used. data were not collected
Time frame: 2 or more years
| Milestone | Transdermal Clonidine/Oral Clonidine | Comparator |
|---|---|---|
| Started | 11 | 11 |
| Completed | 11 | 11 |
| Not completed | 0 | 0 |
data were not collected
No measurements were reported for this outcome.
As assessed by the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) score Data were not collected
Results for this outcome have not been posted.
Hours. data were not collected
Results for this outcome have not been posted.
As assessed by daily CAM score currently used. data were not collected
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Transdermal Clonidine/Oral Clonidine | — | — | — |
| Comparator | — | — | — |
baseline data were not collected
| Age, Continuous | Transdermal Clonidine/Oral Clonidine | Comparator | Total |
|---|
| Sex: Female, Male | Transdermal Clonidine/Oral Clonidine | Comparator | Total |
|---|---|---|---|
| Female | — | — | — |
| Male | — | — | — |
| Adjuvant Sedation and Anxiolysis | Transdermal Clonidine/Oral Clonidine | Comparator | Total |
|---|
This study is terminated, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Memorial Health University Medical Center