Delirium Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | August 2012 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Memorial Health University Medical Center | Savannah | Georgia |
Lead Sponsor | Collaborator |
---|---|
Memorial Health University Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of mechanical ventilation following administration of the first dose of Clonidine or placebo | 2 or more years | No | |
Secondary | Incidence and duration in hours of delirium currently used | As assessed by the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) score | 2 or more years | No |
Secondary | Time to pass first SBT following administration of the first dose of Clonidine or placebo | Hours | 2 or more years | No |
Secondary | Mean incidence and duration of delirium | As assessed by daily CAM score currently used | 2 or more years | No |
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