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Use of Transdermal Clonidine in Trauma Patients

This study is currently recruiting participants.
Verified August 2011 by Memorial Health University Medical Center
Sponsor:
Information provided by:
Memorial Health University Medical Center
ClinicalTrials.gov Identifier:
NCT01139996
First received: June 7, 2010
Last updated: August 17, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Delirium
 Drug: Clonidine
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: A Randomized Double Blinded Placebo Controlled Trial Of Transdermal Clonidine for Adjuvant Sedation in Ventilated Trauma Patients Experiencing Delirium

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Memorial Health University Medical Center:

Primary Outcome Measures:
  • Duration of mechanical ventilation following administration of the first dose of Clonidine or placebo [ Time Frame: 2 or more years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence and duration in hours of delirium currently used [ Time Frame: 2 or more years ] [ Designated as safety issue: No ]
    As assessed by the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) score

  • Time to pass first SBT following administration of the first dose of Clonidine or placebo [ Time Frame: 2 or more years ] [ Designated as safety issue: No ]
    Hours

  • Mean incidence and duration of delirium [ Time Frame: 2 or more years ] [ Designated as safety issue: No ]
    As assessed by daily CAM score currently used


Estimated Enrollment: 120
Study Start Date: May 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transdermal Clonidine/Oral 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
 Drug: Clonidine
An oral loading dose of Clonidine 0.3 mg and placement of Clonidine Transdermal system at a dose of 0.3-mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3mg after 12 hours
Placebo Comparator: Comparator
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
 Drug: Placebo
A placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final tablet

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01139996

Contacts
Contact: Alvaro Fonseca, MD 912 350-7051 fonseal1@memorialhealth.com
Contact: Andrew Gamenthaler, MD 912 350-8598 gamenan1@memorialhealth.com

Locations
United States, Georgia
Memorial Health University Medical Center Recruiting
Savannah, Georgia, United States, 31404
Principal Investigator: Alvaro Fonseca, MD            
Sponsors and Collaborators
Memorial Health University Medical Center
  More Information

No publications provided

Responsible Party: Alvaro Fonseca, MD, Memorial Health University Medical Center
ClinicalTrials.gov Identifier: NCT01139996     History of Changes
Other Study ID Numbers: MHUMC-2010-04-02
Study First Received: June 7, 2010
Last Updated: August 17, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Clonidine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013