Use of Transdermal Clonidine in Trauma Patients

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Delirium

In brief

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.

Key facts

Study ID

NCT01139996

Run by

Memorial Health University Medical Center

People needed

22

Starts

2010-05-01

Expected to finish

2012-08-01

Last updated by the study team

2017-06-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ventilated male or female trauma patient 18 years of age or older admitted to the ICU >24 hours
• Patient must meet minimal medical criteria for potential extubation (meet criteria for being placed on spontaneous breathing trials per established MUMC SBT protocol)
• Patients must exhibit delirium as assessed by the CAM-ICU assessment tool
• Patient must be declared stable from a neurologic, respiratory and cardiovascular standpoint to receive clonidine by the attending MD
• Consent must be obtained prior to any study procedures

You may not qualify if…

• Patient < 18 years old
• Bradycardia (HR < 60)
• Presence of active pacemaker
• Hypotensive (<90/60)or active treatment of hypotension with vasoactive medications
• Patient actively being treated with Clonidine or dexmedetomidine
• Presence of allergy to Clonidine
• Pregnancy

Where it is running

• Memorial Health University Medical Center — Savannah, Georgia, United States

Full record on ClinicalTrials.gov

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