Use of Transdermal Clonidine in Trauma Patients

Phase 4

Terminated

• Conditions: Delirium
• Interventions: Drug: Placebo; Drug: Clonidine

• Registration Number: NCT01139996
• Lead Sponsor: Memorial Health University Medical Center

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-06-07
• Study First Submitted QC: 2010-06-08
• Study First Posted: 2010-06-09
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Results First Submitted: 2017-03-27
• Status Verified: 2017-05
• Results First Submitted QC: 2017-05-15
• Last Update Submitted: 2017-05-15
• Results First Posted: 2017-06-14
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparator	Placebo	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
Transdermal Clonidine/Oral Clonidine	Clonidine	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

Primary Outcome Measures

Name	Time	Method
Duration of Mechanical Ventilation Following Administration of the First Dose of Clonidine or Placebo	2 or more years	data were not collected

Secondary Outcome Measures

Name	Time	Method
Time to Pass First SBT Following Administration of the First Dose of Clonidine or Placebo	2 or more years	Hours. data were not collected
Mean Incidence and Duration of Delirium	2 or more years	As assessed by daily CAM score currently used. data were not collected
Incidence and Duration in Hours of Delirium Currently Used	2 or more years	As assessed by the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) score Data were not collected

Trial Locations

Locations (1)

Memorial Health University Medical Center; 🇺🇸 Savannah, Georgia, United States