Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000381987
Ethics application status
Not yet submitted
Date submitted
12/04/2011
Date registered
13/04/2011
Date last updated
13/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Re-evaluation of Midazolam’s Objective Value by Exclusion
Scientific title
In intubated patients in the intensive care unit, does introducing a unit protocol that restricts the use of midazolam as a sedative used by continuous infusion to a limited set of indications reduce the use of antipsychotic medications and other delirium-sensitive outcomes, in comparison to standard practice in equivalent historical periods.
Secondary ID [1] 259988 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
REMOVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delirium associated with critical illness 265612 0
Condition category
Condition code
Mental Health 265763 265763 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A clinical guideline for intubated patients in the ICU that restricts continuous IV midazolam use to patients with one of a select list of indications: seizures, alcohol withdrawal, requirement for dangerously high doses of other sedatives. The rate of midazolam infusion under these circumstances will be determined by the physician responsible for the patient's ICU management, using standard clinical assessments to measure response, for the duration judged clincially appropriate.
Intervention code [1] 264401 0
Treatment: Drugs
Comparator / control treatment
Historical controls from a period 3 months immediately prior to the introduction of the guideline, and in the equivalent 3 month period in the preceeding year.
Control group
Historical

Outcomes
Primary outcome [1] 266518 0
Antipsychotic use (i.e. total use of quetiapine, haloperidol, olanzapine, dexmedetomidine and clonidine, the agents listed in the ICU delirium protocol)
Timepoint [1] 266518 0
cumulative use (total quantity, number of doses, mean and median dose) over the entire ICU admisison
Secondary outcome [1] 273945 0
hours intubated
Timepoint [1] 273945 0
entire ICU admisison
Secondary outcome [2] 273946 0
ICU length of stay
Timepoint [2] 273946 0
end of ICU admisison
Secondary outcome [3] 273947 0
Hospital length of stay
Timepoint [3] 273947 0
end of Hospital admission
Secondary outcome [4] 273948 0
Use of mechanical restraint while intubated
Timepoint [4] 273948 0
end of ICU admission
Secondary outcome [5] 273949 0
ICU mortality
Timepoint [5] 273949 0
end of ICU admission
Secondary outcome [6] 273950 0
Hospital mortality
Timepoint [6] 273950 0
end of Hospital admission
Secondary outcome [7] 273951 0
Use of alternative sedative agents
Timepoint [7] 273951 0
end of ICU admission

Eligibility
Key inclusion criteria
All mechanically ventilated patients admitted to the ICU in the study period
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All mechanically ventilated patients admitted to the ICU during the study period will be treated using the new, evidence-based guideline.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Before and after design.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264866 0
Hospital
Name [1] 264866 0
Austin Hospital
Country [1] 264866 0
Australia
Primary sponsor type
Hospital
Name
Austin Hospital
Address
Intensive Care Unit
Studley Road
Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 263968 0
None
Name [1] 263968 0
Address [1] 263968 0
Country [1] 263968 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 266826 0
Austin Hospital
Ethics committee address [1] 266826 0
Studley Road
Heidelberg VIC 3084
Ethics committee country [1] 266826 0
Australia
Date submitted for ethics approval [1] 266826 0
12/04/2011
Approval date [1] 266826 0
Ethics approval number [1] 266826 0

Summary
Brief summary
There is abundant observational evidence that midazolam, a benzodiazepine drug used for
sedation, use is associated with delirium in ICU patients. However, despite the availability of an
equally effective alternative, benzodiazepines usage remains high. The most likely explanation
for is that clinicians are not sufficiently convinced by the quality of the observational studies.
This is a reasonable criticism, as it is unlikely that it was possible to adjust for all sources of
indication bias in these studies. We hypothesise that introducing a clinical guideline for
intubated patients in the Austin Hospital ICU that restricts midazolam use to patients with one
of a select list of indications will a. reduce the use of midazolam and b. reduce the incidence of
surrogate markers of delirium in ICU patients, without c. significantly increasing cost of
sedative medications in the ICU.
Trial website
NA
Trial related presentations / publications
NA
Public notes

Contacts
Principal investigator
Name 32478 0
Address 32478 0
Country 32478 0
Phone 32478 0
Fax 32478 0
Email 32478 0
Contact person for public queries
Name 15725 0
A/Prof Michael Reade
Address 15725 0
Austin Hospital ICU
Studley Rd, Heidelberg VIC 3084
Country 15725 0
Australia
Phone 15725 0
+61394965000
Fax 15725 0
+61394963932
Email 15725 0
[email protected]
Contact person for scientific queries
Name 6653 0
A/Prof Michael Reade
Address 6653 0
Austin Hospital ICU
Studley Rd, Heidelberg VIC 3084
Country 6653 0
Australia
Phone 6653 0
+61394965000
Fax 6653 0
+61394963932
Email 6653 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.