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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
Scientific title
A Randomised, Double-blind, Multi-centre Placebo Controlled Trial of Dexmedetomidine for Patients With Agitation and Delirium in the Intensive Care Unit
Secondary ID [1] 0 0
H2010/03891
Universal Trial Number (UTN)
Trial acronym
DahLIA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delirium 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Ventilator-free hours
Timepoint [1] 0 0
7 days following randomisation
Secondary outcome [1] 0 0
Time to ICU discharge
Timepoint [1] 0 0
On hospital discharge, or 6 months (whichever is sooner)
Secondary outcome [2] 0 0
Overall ICU length of stay
Timepoint [2] 0 0
On hospital discharge, or 6 months (whichever is sooner)
Secondary outcome [3] 0 0
Time to first extubation
Timepoint [3] 0 0
On hospital discharge, or 6 months (whichever is sooner)
Secondary outcome [4] 0 0
Time taken to achieve a satisfactory sedation score
Timepoint [4] 0 0
7 days following randomisation
Secondary outcome [5] 0 0
%ICU time spent with a satisfactory sedation score
Timepoint [5] 0 0
7 days following randomisation
Secondary outcome [6] 0 0
%ICU time spent with a satisfactory delirium score
Timepoint [6] 0 0
7 days following randomisation
Secondary outcome [7] 0 0
Time taken to achieve a satisfactory agitation score
Timepoint [7] 0 0
7 days following randomisation
Secondary outcome [8] 0 0
%ICU time spent with a satisfactory agitation score
Timepoint [8] 0 0
7 days following randomisation
Secondary outcome [9] 0 0
Need for supplementary sedative medication
Timepoint [9] 0 0
7 days following randomisation
Secondary outcome [10] 0 0
Need for mechanical restraint
Timepoint [10] 0 0
7 days following randomisation
Secondary outcome [11] 0 0
Need for supplementary antipsychotic medication
Timepoint [11] 0 0
7 days following randomisation
Secondary outcome [12] 0 0
Need for tracheostomy
Timepoint [12] 0 0
On hospital discharge, or 6 months (whichever is sooner)
Secondary outcome [13] 0 0
Acute hospital length of stay
Timepoint [13] 0 0
On hospital discharge, or 6 months (whichever is sooner)
Secondary outcome [14] 0 0
Discharge destination
Timepoint [14] 0 0
On hospital discharge, or 6 months (whichever is sooner)
Secondary outcome [15] 0 0
Daily SOFA score
Timepoint [15] 0 0
7 days following randomisation
Secondary outcome [16] 0 0
ICU mortality
Timepoint [16] 0 0
On hospital discharge, or 6 months (whichever is sooner)
Secondary outcome [17] 0 0
Hospital mortality
Timepoint [17] 0 0
On hospital discharge, or 6 months (whichever is sooner)
Secondary outcome [18] 0 0
Duration and rate of vasopressor support
Timepoint [18] 0 0
7 days following randomisation
Secondary outcome [19] 0 0
Need for insertion of a new central venous catheter to facilitate vasopressor / inotropic support
Timepoint [19] 0 0
7 days following randomisation
Secondary outcome [20] 0 0
Requirement for reintubation
Timepoint [20] 0 0
On hospital discharge, or 6 months (whichever is sooner)

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%.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2013
Sample size
Target
Accrual to date
Final
96
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 0 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [3] 0 0
Northern Hospital - Epping
Recruitment hospital [4] 0 0
The Western Hospital - Footscray
Recruitment hospital [5] 0 0
Austin Hospital - Melbourne
Recruitment hospital [6] 0 0
The Alfred Hospital - Prahran
Recruitment hospital [7] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
4350 - Toowoomba
Recruitment postcode(s) [3] 0 0
3076 - Epping
Recruitment postcode(s) [4] 0 0
3011 - Footscray
Recruitment postcode(s) [5] 0 0
3084 - Melbourne
Recruitment postcode(s) [6] 0 0
3181 - Prahran
Recruitment postcode(s) [7] 0 0
6001 - Perth

Funding & Sponsors
Primary sponsor type
Government body
Name
Austin Health
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Hospira, now a wholly owned subsidiary of Pfizer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Michael C Reade, MBBS DPhil
Address 0 0
Austin Hospital & University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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