Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000085572
Ethics application status
Approved
Date submitted
25/02/2006
Date registered
1/03/2006
Date last updated
5/02/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Dexmedetomidine and Haloperidol for the management of emergence delirium in intensive care
Scientific title
Dexmedetomidine and Haloperidol for the management of emergence delirium in intensive care
Universal Trial Number (UTN)
Trial acronym
DeHedic
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delirium in mechanically ventilated intensive care patients 1049 0
Condition category
Condition code
Neurological 1129 1129 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomised to receive IV Haloperidol 5 mg 6 hourly after loading
Intervention code [1] 921 0
Treatment: Drugs
Comparator / control treatment
Patients will be randomised to receive IV Dexmedetomidine 0.4 to 1.0 mcg/kg/hr for up to 7 days
Control group
Active

Outcomes
Primary outcome [1] 1513 0
1. Number of patients extubated
Timepoint [1] 1513 0
Within 36 hours of enrolment
Primary outcome [2] 1514 0
2. Percentage of patients scoring 0 to + 1 on the Prince of Wales sedation score (POWSS) or a negative Confusion Assessment Method (CAM)
Timepoint [2] 1514 0
At 36 hours of enrolment
Secondary outcome [1] 2717 0
1. Time to extubation in ICU
Timepoint [1] 2717 0
Secondary outcome [2] 2718 0
2. Use of physical restraints in ICU
Timepoint [2] 2718 0
Secondary outcome [3] 2719 0
3. The difference in 24 hour urinary catecholamine
Timepoint [3] 2719 0
At day 1 and 3.
Secondary outcome [4] 2720 0
4. Time to ‘ready for discharge’ from ICU.
Timepoint [4] 2720 0
Secondary outcome [5] 2721 0
5. Re admission to intensive care during hospital stay.
Timepoint [5] 2721 0
Secondary outcome [6] 2722 0
6. Any additional drugs needed during study period including;
a. Haloperidol in the Dexmedetomidine arm.
b. Midazolam and or Propofol.
c. Other antipsychotics.
d. ß blockers
Timepoint [6] 2722 0
Secondary outcome [7] 2723 0
7. Re-intubation
Timepoint [7] 2723 0
Within 24 hours.
Secondary outcome [8] 2724 0
8. Accidental extubation in ICU.
Timepoint [8] 2724 0
Secondary outcome [9] 2725 0
9. Accidental removal of other catheters in ICU.
Timepoint [9] 2725 0
Secondary outcome [10] 2726 0
10. Introduction of a new vasoactive drug during study period i.e. inotropes or pressor.
Timepoint [10] 2726 0
Secondary outcome [11] 2727 0
11. Hospital outcome.
Timepoint [11] 2727 0
Secondary outcome [12] 2728 0
12. Number of CT scans for neurological evaluation in ICU.
Timepoint [12] 2728 0

Eligibility
Key inclusion criteria
1. Patient requiring invasive ventilation for longer than 24 hours. 2. Receiving narcotics and /or sedatives for longer than 24 hours. 3. Development of clinical agitation and/or delirium upon weaning narcotics and/or sedatives on commencement of weaning from mechanical ventilation as per the POWSS. 4. Informed consent signed by person responsible within 24 hours of enrolment.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Allergy to any of the trial drugs.2. Patients who are or likely to be pregnant or lactating.3. Any patient with a Body Mass Index of >304. Patients receiving other long term alpha 2 agonists.5. Involvement in a sedation study within the last 30 days.6. Known opiate or benzodiazepines dependence, treatment for chronic pain or recent detoxification therapy within the last 6 months. 7. Patients on anti-psychotic drugs 8. Known dementia, Parkinsonism or epilepsy.9. Patients with recent cerebro-vascular surgery or traumatic brain injury.10. Any evidence of critical illness polyneuropathy.11. Patient with a recent tracheostomy.12. Recent surgery involving free flap.13. Haemodynamically unstable patients with Systolic blood pressure < 90 mmHg and or Heart rate < 55 / min.14. Patients on CVVHD.15. Patients with hepatic encephalopathy within 14 days.16. Patients with a recent drug overdose or CO poisoning.17. Patients who are Non-English Speaking background.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomised sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated numbers
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/03/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1231 0
Hospital
Name [1] 1231 0
Prince of Wales Hospital
Country [1] 1231 0
Primary sponsor type
Hospital
Name
Prince of Wales Hospital
Address
Country
Australia
Secondary sponsor category [1] 1088 0
None
Name [1] 1088 0
Nil
Address [1] 1088 0
Country [1] 1088 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2560 0
Prince of Wales Hospital ethics
Ethics committee address [1] 2560 0
Ethics committee country [1] 2560 0
Australia
Date submitted for ethics approval [1] 2560 0
Approval date [1] 2560 0
23/11/2004
Ethics approval number [1] 2560 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35295 0
Address 35295 0
Country 35295 0
Phone 35295 0
Fax 35295 0
Email 35295 0
Contact person for public queries
Name 10110 0
Naomi Hammond
Address 10110 0
Intensive Care Unit
Prince of Wales Hospital
Level 1
Dickinson Building
Barker St
Randwick NSW 2031
Country 10110 0
Australia
Phone 10110 0
+61 2 93824720
Fax 10110 0
Email 10110 0
naomi.hammond@sesiahs.health.nsw.gov.au
Contact person for scientific queries
Name 1038 0
Dr Yahya Shehabi
Address 1038 0
Intensive Care Unit
Prince of Wales Hospital
Level 1
Dickinson Building
Barker St
Randwick NSW 2031
Country 1038 0
Australia
Phone 1038 0
+61 2 93824721
Fax 1038 0
Email 1038 0
yshehabi@ozemail.com.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.