A Comparison of Dexmedetomidine and Haloperidol in Patients With Intensive Care Unit (ICU)-Associated Agitation and Delirium (Dex)
Primary Purpose
Delirium, Agitation, Ventilator Weaning
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
dexmedetomidine
haloperidol
Sponsored by
About this trial
This is an interventional treatment trial for Delirium focused on measuring dexmedetomidine, haloperidol
Eligibility Criteria
Inclusion Criteria:
- Patients will be eligible for the study if, in the opinion of the treating clinician, they continue to require mechanical ventilation only because their degree of agitation requires such a high dose of sedative medication (midazolam or propofol, the only commonly used specific sedatives in our unit) that extubation is not possible.
Exclusion Criteria:
Patients who could not be extubated even if delirium or agitation were corrected. This will include:
- Patients receiving high dose opioid analgesia (>20 m/morphine/day)
- Patients shortly to return to the operating theatre
- Patients undergoing repeated invasive procedures, in whom it is desirable to maintain deep sedation.
- Patients likely to require ongoing airway protection or control, or ventilatory support (for example, spinal patients with an inadequate vital capacity)
- Known allergy to haloperidol or alpha2 agonists
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Time from the commencement of treatment to extubation
the tiem taken to extubate the patient
Secondary Outcome Measures
Time taken to achieve a satisfactory sedation score (score 3 or 4 on the Riker scale)
time to sedation score
The need for supplemental sedative and analgesic medication (morphine, midazolam or propofol, as clinically indicated)
Average Riker score for agitation
Average RASS score for agitation
Need for re-intubation
Average Bergeron ICDSC score for delirium
Duration of ICU stay
Full Information
NCT ID
NCT00505804
First Posted
July 23, 2007
Last Updated
January 22, 2013
Sponsor
Austin Health
Collaborators
The Alfred
1. Study Identification
Unique Protocol Identification Number
NCT00505804
Brief Title
A Comparison of Dexmedetomidine and Haloperidol in Patients With Intensive Care Unit (ICU)-Associated Agitation and Delirium
Acronym
Dex
Official Title
A Randomised Open Label Pilot Study of the Efficacy of Dexmedetomidine and Haloperidol in Ventilated Patients With ICU-associated Agitation and Delirium
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Austin Health
Collaborators
The Alfred
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to determine whether dexmedetomidine is a more effective medication than haloperidol in the treatment of agitation and delirium in patients receiving mechanical ventilation in an intensive care unit. Haloperidol is a medication conventionally used for this purpose.
The investigators will study only patients who have recovered from their illness to the point that, were it not for agitation and delirium, they would no longer require mechanical ventilation.
The investigators hypothesize that patients receiving dexmedetomidine will be able to discontinue mechanical ventilation earlier than those receiving haloperidol.
Detailed Description
Up to 80% of patients undergoing intensive care have delirium. Early in the ICU stay, delirium and agitation are usually prevented using analgesic and sedative drugs which essentially render the patient unconscious. This is appropriate in the context of aggressive treatment of pathophysiological instability, which often requires multiple painful procedures. However, after the underlying pathophysiological problem has resolved, patients sometimes remain delirious and agitated. This often requires ongoing heavy sedation, which in turn necessitates continued mechanical ventilation, and can worsen the (temporarily masked) delirium. Prolonged mechanical ventilation increases the risk of ventilator associated pneumonia and other life threatening complications.
The drug most commonly used to treat delirium is haloperidol, which reduces hallucinations and unstructured thought patterns, but also reduces the interaction with the environment. Haloperidol has significant side effects, including extrapyramidal reactions (in 1-10% of patients), neuroleptic malignant syndrome (in which it is the cause in 50% of cases), and prolonged QT syndrome (which can precipitate fatal arrhythmias).
An ideal sedative agent in this context would have fewer side effects, relieve agitation without causing excessive sedation, and be easily titrated. An analgesic action might allow less opioid use, also lessening delirium. Early studies in other contexts suggest dexmedetomidine has all these properties.
The investigators hypothesise that patients with ICU-associated delirium after the resolution of their underlying pathological process who receive dexmedetomidine will be able to be extubated earlier than those who receive haloperidol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Agitation, Ventilator Weaning, Respiration, Artificial, Intensive Care
Keywords
dexmedetomidine, haloperidol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine
Intervention Description
Dexmedetomidine IV infusion of 0.0 to 0.7 mg/kg/min for as long a deemed necessary by the treating clinician.
Intervention Type
Drug
Intervention Name(s)
haloperidol
Intervention Description
Haloperidol IV loading dose of 2.5mg, followed by a continuous infusion of 0.0 to 2mg/hr for as long as deemed necessary by the treating clinician
Primary Outcome Measure Information:
Title
Time from the commencement of treatment to extubation
Description
the tiem taken to extubate the patient
Time Frame
days
Secondary Outcome Measure Information:
Title
Time taken to achieve a satisfactory sedation score (score 3 or 4 on the Riker scale)
Description
time to sedation score
Time Frame
hours
Title
The need for supplemental sedative and analgesic medication (morphine, midazolam or propofol, as clinically indicated)
Time Frame
During delivery of trial medication
Title
Average Riker score for agitation
Time Frame
During delivery of trial medication
Title
Average RASS score for agitation
Time Frame
During delivery of trial medication
Title
Need for re-intubation
Time Frame
During the same ICU admission
Title
Average Bergeron ICDSC score for delirium
Time Frame
During delivery of trial medication
Title
Duration of ICU stay
Time Frame
days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients will be eligible for the study if, in the opinion of the treating clinician, they continue to require mechanical ventilation only because their degree of agitation requires such a high dose of sedative medication (midazolam or propofol, the only commonly used specific sedatives in our unit) that extubation is not possible.
Exclusion Criteria:
Patients who could not be extubated even if delirium or agitation were corrected. This will include:
Patients receiving high dose opioid analgesia (>20 m/morphine/day)
Patients shortly to return to the operating theatre
Patients undergoing repeated invasive procedures, in whom it is desirable to maintain deep sedation.
Patients likely to require ongoing airway protection or control, or ventilatory support (for example, spinal patients with an inadequate vital capacity)
Known allergy to haloperidol or alpha2 agonists
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rinaldo Bellomo, MD FJFICM
Organizational Affiliation
Austin Health, University of Melbourne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael C Reade, MBBS FJFICM
Organizational Affiliation
Austin Health, University of Melbourne
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
19454032
Citation
Reade MC, O'Sullivan K, Bates S, Goldsmith D, Ainslie WR, Bellomo R. Dexmedetomidine vs. haloperidol in delirious, agitated, intubated patients: a randomised open-label trial. Crit Care. 2009;13(3):R75. doi: 10.1186/cc7890. Epub 2009 May 19.
Results Reference
derived
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A Comparison of Dexmedetomidine and Haloperidol in Patients With Intensive Care Unit (ICU)-Associated Agitation and Delirium
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