A Comparison of Dexmedetomidine and Haloperidol in Patients With Intensive Care Unit (ICU)-Associated Agitation and Delirium (Dex)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomised Open Label Pilot Study of the Efficacy of Dexmedetomidine and Haloperidol in Ventilated Patients With ICU-associated Agitation and Delirium|
- Time from the commencement of treatment to extubation [ Time Frame: days ] [ Designated as safety issue: No ]the tiem taken to extubate the patient
- Time taken to achieve a satisfactory sedation score (score 3 or 4 on the Riker scale) [ Time Frame: hours ] [ Designated as safety issue: No ]time to sedation score
- The need for supplemental sedative and analgesic medication (morphine, midazolam or propofol, as clinically indicated) [ Time Frame: During delivery of trial medication ] [ Designated as safety issue: No ]
- Average Riker score for agitation [ Time Frame: During delivery of trial medication ] [ Designated as safety issue: No ]
- Average RASS score for agitation [ Time Frame: During delivery of trial medication ] [ Designated as safety issue: Yes ]
- Need for re-intubation [ Time Frame: During the same ICU admission ] [ Designated as safety issue: Yes ]
- Average Bergeron ICDSC score for delirium [ Time Frame: During delivery of trial medication ] [ Designated as safety issue: No ]
- Duration of ICU stay [ Time Frame: days ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2005|
|Study Completion Date:||November 2008|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
Dexmedetomidine IV infusion of 0.0 to 0.7 mg/kg/min for as long a deemed necessary by the treating clinician.
|Active Comparator: 2||
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00505804
|Principal Investigator:||Rinaldo Bellomo, MD FJFICM||Austin Health, University of Melbourne|
|Study Director:||Michael C Reade, MBBS FJFICM||Austin Health, University of Melbourne|