DeliriumPhase 2DexNCT00505804
A Comparison of Dexmedetomidine and Haloperidol in Patients With Intensive Care Unit (ICU)-Associated Agitation and Delirium
A Phase 2 study testing dexmedetomidine and haloperidol in people with Delirium and Agitation, run by Austin Health.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium, Agitation, Ventilator Weaning
- What is being tested?
- dexmedetomidine and haloperidol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Nov 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: A Randomised Open Label Pilot Study of the Efficacy of Dexmedetomidine and Haloperidol in Ventilated Patients With ICU-associated Agitation and Delirium
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.
Read the 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.
- Conditions
- Delirium, Agitation, Ventilator Weaning, Respiration, Artificial, Intensive Care
- Being tested
- dexmedetomidine, haloperidol
- Keywords
- dexmedetomidine, haloperidol
- Medical subject headings
- Delirium, Psychomotor Agitation, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidineDrug
Dexmedetomidine IV infusion of 0.0 to 0.7 mg/kg/min for as long a deemed necessary by the treating clinician.
haloperidolDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: dexmedetomidine |
| 2 | Active comparator | Not described Receives: Drug: haloperidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from the commencement of treatment to extubation
the tiem taken to extubate the patient
Measured: days
Secondary outcomes (7)
Time taken to achieve a satisfactory sedation score (score 3 or 4 on the Riker scale)
time to sedation score
Measured: hours
The need for supplemental sedative and analgesic medication (morphine, midazolam or propofol, as clinically indicated)
Measured: During delivery of trial medication
Average Riker score for agitation
Measured: During delivery of trial medication
Average RASS score for agitation
Measured: During delivery of trial medication
Need for re-intubation
Measured: During the same ICU admission
Average Bergeron ICDSC score for delirium
Measured: During delivery of trial medication
Duration of ICU stay
Measured: days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startJan 2005
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Austin Health
- Sponsor type
- Other government
- Collaborators
- The Alfred
- Responsible party
- Principal investigator, Rinaldo Bellomo, Austin Health
- Investigators
- Rinaldo Bellomo, MD FJFICM, Principal investigator, Austin Health, University of MelbourneMichael C Reade, MBBS FJFICM, Study director, Austin Health, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505804
- Sponsor's protocol ID
- H2004/02026
- Acronym
- Dex
- Status last verified
- Jan 2013
- First submitted
- 23 Jul 2007
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19454032
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Open Label Pilot Study of the Efficacy of Dexmedetomidine and Haloperidol in Ventilated Patients With ICU-associated Agitation and Delirium
- ClinicalTrials.gov ID
- NCT00505804
- Acronym / sponsor ID
- Dex / H2004/02026
- Conditions
- Delirium, Agitation, Ventilator Weaning, Respiration, Artificial, Intensive Care
- Keywords
- dexmedetomidine, haloperidol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Austin HealthOther government
- Collaborators
- The Alfred
- Study start
- Jan 2005
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 25 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: dexmedetomidine |
| 2 | Active comparator | Drug: haloperidol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- Patients who could not be extubated even if delirium or agitation were corrected. This will include:
- Known allergy to haloperidol or alpha2 agonists
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexmedetomidineDexmedetomidine IV infusion of 0.0 to 0.7 mg/kg/min for as long a deemed necessary by the treating clinician. | Drug | 1 |
| haloperidolHaloperidol 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 | Drug | 2 |
Primary outcome
Time from the commencement of treatment to extubation
Time frame: days
the tiem taken to extubate the patient
7 secondary outcomes
Time taken to achieve a satisfactory sedation score (score 3 or 4 on the Riker scale)
Time frame: hours
The need for supplemental sedative and analgesic medication (morphine, midazolam or propofol, as clinically indicated)
Time frame: During delivery of trial medication
Average Riker score for agitation
Time frame: During delivery of trial medication
Average RASS score for agitation
Time frame: During delivery of trial medication
Need for re-intubation
Time frame: During the same ICU admission
Average Bergeron ICDSC score for delirium
Time frame: During delivery of trial medication
Duration of ICU stay
Time frame: days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
- Derived from this study: PubMed 19454032Reade 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rinaldo Bellomo, MD FJFICM principal investigator
Austin Health, University of Melbourne
Michael C Reade, MBBS FJFICM study director
Austin Health, University of Melbourne
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dexmedetomidine and haloperidol in people with Delirium and Agitation, run by Austin Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from the commencement of treatment to extubation (time frame: days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00505804, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2013.