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Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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Trial registered on ANZCTR
Registration number
ACTRN12605000062628
Ethics application status
Approved
Date submitted
27/07/2005
Date registered
1/08/2005
Date last updated
1/08/2005
Type of registration
Prospectively registered
Titles & IDs
Public title
Placebo versus Adrenaline in Cardiac Arrest
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Scientific title
A randomised placebo controlled trial of adrenaline in improving survival from out of hospital cardiac arrest.
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Universal Trial Number (UTN)
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Trial acronym
PACA Trial
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Out of hospital cardiac arrest
134
0
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Condition category
Condition code
Cardiovascular
153
153
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Adrenaline 1:1000 according to current resuscitation guidelines
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Intervention code [1]
73
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Treatment: Drugs
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Comparator / control treatment
Placebo (0.9% Sodium Chloride)
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Control group
Placebo
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Outcomes
Primary outcome [1]
189
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Survival to hospital discharge
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Assessment method [1]
189
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Timepoint [1]
189
0
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Secondary outcome [1]
437
0
Return of Spontaneous Circulation
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Assessment method [1]
437
0
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Timepoint [1]
437
0
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Secondary outcome [2]
438
0
Neurological function
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Assessment method [2]
438
0
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Timepoint [2]
438
0
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Eligibility
Key inclusion criteria
All patients who suffer a cardiac arrest ouitside of hospital.
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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
Advanced life support measures not initiated.
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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)
Numbered vials - concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised random number generation
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/10/2005
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Actual
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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
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Sample size
Target
4500
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
205
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Government body
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Name [1]
205
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National Health and Medical Research Council
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Address [1]
205
0
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Country [1]
205
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Australia
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Primary sponsor type
University
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Name
University of Western Australia
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Address
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Country
Australia
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Secondary sponsor category [1]
154
0
None
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Name [1]
154
0
Nil
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Address [1]
154
0
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Country [1]
154
0
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Ethics approval
Ethics application status
Approved
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Summary
Brief summary
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
35426
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Address
35426
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Country
35426
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Phone
35426
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Fax
35426
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Email
35426
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Contact person for public queries
Name
9262
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Associate Professor Ian Jacobs
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Address
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Emergency Medicine
University of Western Australia
M516
35 Stirling Hwy
Crawley WA 6009
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Country
9262
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Australia
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Phone
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+61 8 93464354
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Fax
9262
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+61 8 93461665
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Email
9262
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[email protected]
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Contact person for scientific queries
Name
190
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Associate Professor Ian Jacobs
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Address
190
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Emergency Medicine
University of Western Australia
M516
35 Stirling Hwy
Crawley WA 6009
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Country
190
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Australia
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Phone
190
0
+61 8 93464354
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Fax
190
0
+61 8 93461665
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Email
190
0
[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
The effects of adrenaline in out of hospital cardiac arrest with shockable and non-shockable rhythms: Findings from the PACA and PARAMEDIC-2 randomised controlled trials.
2019
https://dx.doi.org/10.1016/j.resuscitation.2019.05.007
N.B. These documents automatically identified may not have been verified by the study sponsor.
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