Use of Transdermal Clonidine in Trauma Patients
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/13/2015 |
| Start Date: | May 2010 |
| End Date: | May 2012 |
| Contact: | Alvaro Fonseca, MD |
| Email: | fonseal1@memorialhealth.com |
| Phone: | 912 350-7051 |
A Randomized Double Blinded Placebo Controlled Trial Of Transdermal Clonidine for Adjuvant Sedation in Ventilated Trauma Patients Experiencing Delirium
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.
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.
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.
Inclusion Criteria:
1. Ventilated male or female trauma patient 18 years of age or older admitted to the ICU
>24 hours
2. Patient must meet minimal medical criteria for potential extubation (meet criteria
for being placed on spontaneous breathing trials per established MUMC SBT protocol)
3. Patients must exhibit delirium as assessed by the CAM-ICU assessment tool
4. Patient must be declared stable from a neurologic, respiratory and cardiovascular
standpoint to receive clonidine by the attending MD
5. Consent must be obtained prior to any study procedures
Exclusion Criteria:
1. Patient < 18 years old
2. Bradycardia (HR < 60)
3. Presence of active pacemaker
4. Hypotensive (<90/60)or active treatment of hypotension with vasoactive medications
5. Patient actively being treated with Clonidine or dexmedetomidine
6. Presence of allergy to Clonidine
7. Pregnancy
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Memorial Health University Medical Center Memorial University Medical Center (MUMC) is a nonprofit, 622-bed tertiary...
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