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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01151865
Registration number
NCT01151865
Ethics application status
Date submitted
18/06/2010
Date registered
29/06/2010
Date last updated
21/01/2015
Titles & IDs
Public title
Dexmedetomidine to Lessen Intensive Care Unit (ICU) Agitation
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Scientific title
A Randomised, Double-blind, Multi-centre Placebo Controlled Trial of Dexmedetomidine for Patients With Agitation and Delirium in the Intensive Care Unit
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Secondary ID [1]
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H2010/03891
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Universal Trial Number (UTN)
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Trial acronym
DahLIA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Delirium
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Condition category
Condition code
Neurological
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Other neurological disorders
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Mental Health
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Other mental health disorders
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Mental Health
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Psychosis and personality disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Dexmedetomidine
Treatment: Drugs - Saline placebo
Active comparator: Dexmedetomidine - Dexmedetomidine will be administered intravenously as a maintenance infusion of 0.2 to 1.5 mcg/kg/hour, commencing at 0.5 mcg/kg/hour and titrated according to effect, for as long as deemed necessary by the treating physician. Specifically, the study medication may be (as recommended by the manufacturer) continued after extubation, and if discontinued may be restarted at any time up until ICU discharge. The clinician will have the option of using a loading dose of 1.0 mcg/kg IV over 20 minutes, as recommended by the manufacturer.
Bedside nursing staff will adjust drug infusion rates as necessary, in consultation with the treating physician, aiming to achieve a Riker Sedation-Agitation Scale 20 score of 4.
Placebo comparator: Saline placebo - An identical syringe to that in the intervention arm, but which does not contain dexmedetomidine, will be provided. The initial rate of infusion and subsequent adjustments will be the same as in the dexmedetomidine group.
Treatment: Drugs: Dexmedetomidine
Dexmedetomidine will be administered intravenously as a maintenance infusion of 0.2 to 1.5 mcg/kg/hour, commencing at 0.5 mcg/kg/hour and titrated according to effect, for as long as deemed necessary by the treating physician. Specifically, the study medication may be (as recommended by the manufacturer) continued after extubation, and if discontinued may be restarted at any time up until ICU discharge. The clinician will have the option of using a loading dose of 1.0 mcg/kg IV over 20 minutes, as recommended by the manufacturer.
Bedside nursing staff will adjust drug infusion rates as necessary, in consultation with the treating physician, aiming to achieve a Riker Sedation-Agitation Scale 20 score of 4.
Treatment: Drugs: Saline placebo
An identical syringe containing only saline with no dexmedetomidine added will be supplied. Initial rate of infusion and subsequent adjustments will be the same as in the active comparator group.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Ventilator-free hours
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Assessment method [1]
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The primary outcome measure for the study will be the number of ventilator-free hours in the incident ICU admission in the 7 days following commencement of trial medication, in patients randomised to receive dexmedetomidine or normal saline placebo while receiving all other aspects of standard care.
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Timepoint [1]
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7 days following randomisation
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Secondary outcome [1]
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Time to ICU discharge
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Assessment method [1]
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Timepoint [1]
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On hospital discharge, or 6 months (whichever is sooner)
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Secondary outcome [2]
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Overall ICU length of stay
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Assessment method [2]
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Timepoint [2]
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On hospital discharge, or 6 months (whichever is sooner)
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Secondary outcome [3]
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Time to first extubation
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Assessment method [3]
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Timepoint [3]
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On hospital discharge, or 6 months (whichever is sooner)
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Secondary outcome [4]
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Time taken to achieve a satisfactory sedation score
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Assessment method [4]
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Time taken to achieve RASS score -2 to +1 and RIKER score 3 or 4
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Timepoint [4]
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7 days following randomisation
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Secondary outcome [5]
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%ICU time spent with a satisfactory sedation score
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Assessment method [5]
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%ICU time spent with RASS -2 to +1 and RIKER 3 or 4
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Timepoint [5]
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7 days following randomisation
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Secondary outcome [6]
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%ICU time spent with a satisfactory delirium score
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Assessment method [6]
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% time spent with a negative CAM-ICU assessment
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Timepoint [6]
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7 days following randomisation
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Secondary outcome [7]
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Time taken to achieve a satisfactory agitation score
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Assessment method [7]
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Time taken to achieve a MAAS score 2-4
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Timepoint [7]
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7 days following randomisation
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Secondary outcome [8]
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%ICU time spent with a satisfactory agitation score
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Assessment method [8]
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%ICU time spent with a MAAS score 2-4
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Timepoint [8]
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7 days following randomisation
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Secondary outcome [9]
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Need for supplementary sedative medication
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Assessment method [9]
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total infusion time, mean hourly dose and total dose of propofol, morphine and midazolam.
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Timepoint [9]
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7 days following randomisation
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Secondary outcome [10]
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Need for mechanical restraint
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Assessment method [10]
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Time to first not requiring restraint and % ICU time spent without mechanical restraint in the 7 days following commencement of trial medication
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Timepoint [10]
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7 days following randomisation
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Secondary outcome [11]
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Need for supplementary antipsychotic medication
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Assessment method [11]
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Number of doses and total mg delivered of haloperidol, olanzapine, quetiapine, or other anti-psychotic medication as prescribed by the treating physician
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Timepoint [11]
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7 days following randomisation
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Secondary outcome [12]
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Need for tracheostomy
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Assessment method [12]
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Tracheostomy deemed to be necessary by the treating physician, and actually performed.
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Timepoint [12]
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On hospital discharge, or 6 months (whichever is sooner)
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Secondary outcome [13]
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Acute hospital length of stay
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Assessment method [13]
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Total duration of admission to the acute hospital, prior to discharge to home or a skilled or unskilled nursing facility.
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Timepoint [13]
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On hospital discharge, or 6 months (whichever is sooner)
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Secondary outcome [14]
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Discharge destination
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Assessment method [14]
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Discharge to home, a skilled nursing facility, residential care, a physical rehabilitation facility, or death.
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Timepoint [14]
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On hospital discharge, or 6 months (whichever is sooner)
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Secondary outcome [15]
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Daily SOFA score
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Assessment method [15]
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Daily SOFA score with recording of the component parts
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Timepoint [15]
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7 days following randomisation
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Secondary outcome [16]
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ICU mortality
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Assessment method [16]
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ICU mortality
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Timepoint [16]
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On hospital discharge, or 6 months (whichever is sooner)
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Secondary outcome [17]
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Hospital mortality
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Assessment method [17]
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Death in the acute care hospital
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Timepoint [17]
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On hospital discharge, or 6 months (whichever is sooner)
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Secondary outcome [18]
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Duration and rate of vasopressor support
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Assessment method [18]
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total infusion time, and mean hourly dose of noradrenaline and any other inotrope or vasopressor
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Timepoint [18]
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7 days following randomisation
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Secondary outcome [19]
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Need for insertion of a new central venous catheter to facilitate vasopressor / inotropic support
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Assessment method [19]
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Timepoint [19]
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7 days following randomisation
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Secondary outcome [20]
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Requirement for reintubation
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Assessment method [20]
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Reintubation of the trachea to facilitate airway protection or mechanical ventilation, as indicated in the opinion of the treating physician
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Timepoint [20]
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On hospital discharge, or 6 months (whichever is sooner)
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Eligibility
Key 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, AND in the opinion of their treating intensivist their agitation is so severe as to make lessening their sedation unsafe.
These criteria will be objectively quantified as follows:
* they have required either mechanical restraint and/or anti-delirium or sedative medication in the 4 hours prior to seeking consent AND
* their Confusion Assessment Method for the ICU (CAM-ICU) test is positive for delirium in the 4 hours prior to seeking consent AND
* their Motor Activity Assessment Scale (MAAS) score is 5 or more in the 4 hours prior to seeking consent, confirming psychomotor agitation AND
* their SOFA score is less than or equal to 5 in the 4 hours prior to seeking consent, predicting a mortality or around 5%.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Age less than 18 years old
* Pregnancy or breastfeeding
* Advanced dementia (in the premorbid state requiring professional nursing care)
* Open or closed head injury
* Death is deemed imminent and inevitable
* The patient has previously been enrolled in the DahLIA study
* Patients who could not be extubated, or who would be intubated within the following 48 hours, even if delirium or agitation were corrected. This will include:
* Patients receiving high dose opioid for analgesia (not sedation) ( > 40 mg/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 alpha 2 agonists
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2013
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Sample size
Target
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Accrual to date
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Final
96
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Royal North Shore Hospital - St Leonards
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Recruitment hospital [2]
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Toowoomba Hospital - Toowoomba
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Recruitment hospital [3]
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Northern Hospital - Epping
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Recruitment hospital [4]
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The Western Hospital - Footscray
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Recruitment hospital [5]
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Austin Hospital - Melbourne
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Recruitment hospital [6]
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The Alfred Hospital - Prahran
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Recruitment hospital [7]
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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2065 - St Leonards
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Recruitment postcode(s) [2]
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4350 - Toowoomba
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Recruitment postcode(s) [3]
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3076 - Epping
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Recruitment postcode(s) [4]
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3011 - Footscray
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Recruitment postcode(s) [5]
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3084 - Melbourne
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Recruitment postcode(s) [6]
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3181 - Prahran
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Recruitment postcode(s) [7]
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6001 - Perth
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Funding & Sponsors
Primary sponsor type
Government body
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Name
Austin Health
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Hospira, now a wholly owned subsidiary of Pfizer
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary aim of the DahLIA trial is to determine, in patients with ICU-associated delirium and agitation who are otherwise pathophysiologically stable (as defined), the number of ventilator-free hours in the incident ICU admission in the 7 days following commencement of trial medication, in patients randomised to receive dexmedetomidine or placebo while receiving all other aspects of standard care. The null hypothesis assumes no difference in the median number of ventilator-free hours in this ICU admission in the following 7 days, between patients receiving dexmedetomidine and placebo for ICU-associated agitation and delirium.
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Trial website
https://clinicaltrials.gov/study/NCT01151865
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Trial related presentations / publications
Reade MC, Eastwood GM, Bellomo R, Bailey M, Bersten A, Cheung B, Davies A, Delaney A, Ghosh A, van Haren F, Harley N, Knight D, McGuiness S, Mulder J, O'Donoghue S, Simpson N, Young P; DahLIA Investigators; Australian and New Zealand Intensive Care Society Clinical Trials Group. Effect of Dexmedetomidine Added to Standard Care on Ventilator-Free Time in Patients With Agitated Delirium: A Randomized Clinical Trial. JAMA. 2016 Apr 12;315(14):1460-8. doi: 10.1001/jama.2016.2707. Erratum In: JAMA. 2016 Aug 16;316(7):775. doi: 10.1001/jama.2016.9458.
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Public notes
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Contacts
Principal investigator
Name
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Michael C Reade, MBBS DPhil
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Address
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Austin Hospital & University of Melbourne
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Contact person for scientific queries
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
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01151865
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