Trial Review

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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
Scientific title
A randomised placebo controlled trial of adrenaline in improving survival from out of hospital cardiac arrest.
Universal Trial Number (UTN)
Trial acronym
PACA Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Out of hospital cardiac arrest 134 0
Condition category
Condition code
Cardiovascular 153 153 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adrenaline 1:1000 according to current resuscitation guidelines
Intervention code [1] 73 0
Treatment: Drugs
Comparator / control treatment
Placebo (0.9% Sodium Chloride)
Control group
Placebo

Outcomes
Primary outcome [1] 189 0
Survival to hospital discharge
Timepoint [1] 189 0
Secondary outcome [1] 437 0
Return of Spontaneous Circulation
Timepoint [1] 437 0
Secondary outcome [2] 438 0
Neurological function
Timepoint [2] 438 0

Eligibility
Key inclusion criteria
All patients who suffer a cardiac arrest ouitside of hospital.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Advanced life support measures not initiated.

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)
Numbered vials - concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised random number generation
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
1/10/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
4500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 205 0
Government body
Name [1] 205 0
National Health and Medical Research Council
Country [1] 205 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
Country
Australia
Secondary sponsor category [1] 154 0
None
Name [1] 154 0
Nil
Address [1] 154 0
Country [1] 154 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35426 0
Address 35426 0
Country 35426 0
Phone 35426 0
Fax 35426 0
Email 35426 0
Contact person for public queries
Name 9262 0
Associate Professor Ian Jacobs
Address 9262 0
Emergency Medicine
University of Western Australia
M516
35 Stirling Hwy
Crawley WA 6009
Country 9262 0
Australia
Phone 9262 0
+61 8 93464354
Fax 9262 0
+61 8 93461665
Email 9262 0
ijacobs@cyllene.uwa.edu.au
Contact person for scientific queries
Name 190 0
Associate Professor Ian Jacobs
Address 190 0
Emergency Medicine
University of Western Australia
M516
35 Stirling Hwy
Crawley WA 6009
Country 190 0
Australia
Phone 190 0
+61 8 93464354
Fax 190 0
+61 8 93461665
Email 190 0
ijacobs@cyllene.uwa.edu.au

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
SourceTitleYear of PublicationDOI
EmbaseThe 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.2019https://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.