Overview

Use of Transdermal Clonidine in Trauma Patients

Status:
Terminated

Trial end date:
2012-08-01

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Memorial Health University Medical Center

Treatments:

Clonidine

Criteria

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