Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000043639
Ethics application status
Approved
Date submitted
8/07/2005
Date registered
26/07/2005
Date last updated
26/07/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
A routine daily interuption to sedation
Scientific title
A randomised, placebo controlled, trial evaluating the impact of a routine daily interruption, versus adhoc interruption, to continuous infusion of sedatives in mechanically ventilated patients on length of mechanical ventilation and 6 month psychological outcome.
Universal Trial Number (UTN)
Trial acronym
AROUSE study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sedated Mechanically Ventilated ICU patients 109 0
Condition category
Condition code
Other 128 128 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Every patient enrolled in the study will have their prescribed sedation ceased, and a replacement infusion started at 9am each morning. Patients randomised to the intervention group will receive a replacement infusion of normal saline and thus have their continuous sedative infusions interrupted each day. The duration of replacement infusion for both groups will be dependant on patient response during the replacement infusion which is to run for a maximum of 6 hours. Patients will have their replacement infusion ceased and be returned to their prescribed sedative infusion should they experience increasing levels of discomfort, pain or agitation or at 3pm each afternoon, which ever comes first.
Intervention code [1] 6 0
None
Comparator / control treatment
Patients randomised to the control group will receive replacement infusions indentical to their prescribed sedation and thus will continue to receive continuous infusion of sedatives.
Control group
Placebo

Outcomes
Primary outcome [1] 163 0
Length of Mechanical Ventilation
Timepoint [1] 163 0
Secondary outcome [1] 358 0
Incidence of symptoms of post-traumatic stress disorder symptoms
Timepoint [1] 358 0
At 6-months after ICU admission.

Eligibility
Key inclusion criteria
Predicted to require treatment via continuous infusion of sedation to tolerate mechanical ventilation for greater than 48 hours.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Admitted for treatment of neurological or neurosurgical diagnosis. Under the care of a mental health team.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Treatment assignment will be as per a random number generated list, with variable block sizes of four to six.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 177 0
Hospital
Name [1] 177 0
Nepean Hospital Critical Care Research Fund
Country [1] 177 0
Australia
Primary sponsor type
Hospital
Name
Department of Critical Care Medicine, Nepean Hospital.
Address
Country
Australia
Secondary sponsor category [1] 133 0
None
Name [1] 133 0
Not applicable
Address [1] 133 0
Country [1] 133 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 945 0
Nepean Hospital
Ethics committee address [1] 945 0
Ethics committee country [1] 945 0
Australia
Date submitted for ethics approval [1] 945 0
Approval date [1] 945 0
Ethics approval number [1] 945 0

Summary
Brief summary
Continuous infusions of sedatives are commonly used in Australian Intensive Care Units (ICUs) to provide patient comfort and promote tolerance of ICU treatment. These infusions are occasionally stopped to allow patients to return to consciousness to enable assessment of their neurological function and sedation requirements. A routine daily interruption to sedation has been recommended as a standard of care in ICU patients (Dellinger, Crit Care Med, 2004). This recommendation is based on the work of Kress (NEJM, 2000) who enrolled 180 patients in a medical ICU in Chicago. Several aspects of this work significantly reduce the appropriateness of generalising these results to Australian ICU practice. Fully exploring the impact of a daily interruption to sedation is warranted in the context of Australian ICU practice prior to its adoption as a standard of care. In this pilot study, the standard practice of interruption to sedation on an ad-hoc basis will be compared to a routine interruption to sedation for a defined period each day in Australian ICUs. These comparisons will be based on the length of time that mechanical ventilation, ICU and hospital treatment is required and psychological well being 6 months after discharge from ICU. All patients enrolled in the study will be given an infusion replacing their prescribed sedation for a defined period each day. The replacement infusions will be either normal saline or identical to the patients prescribed sedation. This pilot study will test the proposed blinding procedures and facilitate an appropriate power calculation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36248 0
Address 36248 0
Country 36248 0
Phone 36248 0
Fax 36248 0
Email 36248 0
Contact person for public queries
Name 9195 0
Professor Sharon McKinley
Address 9195 0
Critical Care Professorial Unit
Royal North Shore Hospital
Level 6
St Leonards NSW 2065
Country 9195 0
Australia
Phone 9195 0
+61 2 95145735
Fax 9195 0
Email 9195 0
[email protected]
Contact person for scientific queries
Name 123 0
Leonie Weisbrodt
Address 123 0
Intensive Care Unit
Nepean Hospital
Derby St
Penrith NSW 2751
Country 123 0
Australia
Phone 123 0
+61 2 47341388
Fax 123 0
+61 2 47343134
Email 123 0
[email protected]

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.