Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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 information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000179639
Ethics application status
Approved
Date submitted
15/08/2005
Date registered
19/08/2005
Date last updated
19/08/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Paramedic cooling compared with hospital cooling after resuscitation from cardiac arrest
Scientific title
The effect on outcome at hospital discharge of paramedic cooling compared with hospital cooling after resuscitation from cardiac arrest (Outcome: Return to independent living).
Universal Trial Number (UTN)
Trial acronym
The RICH study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Out-of-hospital cardiac arrest 275 0
Condition category
Condition code
Other 309 309 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention code [1] 198 0
Treatment: Other
Comparator / control treatment
he control group receive standard advanced life support care, without cooling attempts.
Control group
Active

Outcomes
Primary outcome [1] 364 0
Good outcome at hospital discharge
Timepoint [1] 364 0
Primary outcome [2] 365 0
Return to independent living defined as discharge to home or rehabilitation
Timepoint [2] 365 0
Secondary outcome [1] 817 0
Mortality rate
Timepoint [1] 817 0
At 12 months
Secondary outcome [2] 818 0
Glasgow-Pittsburgh Cereberal Performance Category
Timepoint [2] 818 0
At 12 months

Eligibility
Key inclusion criteria
Out-of-hospital cardiac arrest, Return of circulation.
Minimum age
17 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy, Trauma, pulmonary oedema, pre-existing poor quality of life.

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)
opage envelopes with treatment allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer random number
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
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
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 368 0
Government body
Name [1] 368 0
National Health and Medical Research Council
Country [1] 368 0
Australia
Primary sponsor type
Other
Name
Metropolitan Ambulance Service
Address
Country
Australia
Secondary sponsor category [1] 291 0
University
Name [1] 291 0
Monash University Department of Epidemiology and Preventive Medicine
Address [1] 291 0
Country [1] 291 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1350 0
Southern Health
Ethics committee address [1] 1350 0
Ethics committee country [1] 1350 0
Australia
Date submitted for ethics approval [1] 1350 0
Approval date [1] 1350 0
Ethics approval number [1] 1350 0
Ethics committee name [2] 1351 0
Peninsula Health
Ethics committee address [2] 1351 0
Ethics committee country [2] 1351 0
Australia
Date submitted for ethics approval [2] 1351 0
Approval date [2] 1351 0
Ethics approval number [2] 1351 0
Ethics committee name [3] 1352 0
Eastern Health
Ethics committee address [3] 1352 0
Ethics committee country [3] 1352 0
Australia
Date submitted for ethics approval [3] 1352 0
Approval date [3] 1352 0
Ethics approval number [3] 1352 0
Ethics committee name [4] 1353 0
Epworth Hospital
Ethics committee address [4] 1353 0
Ethics committee country [4] 1353 0
Australia
Date submitted for ethics approval [4] 1353 0
Approval date [4] 1353 0
Ethics approval number [4] 1353 0
Ethics committee name [5] 1354 0
Alfred Hospital
Ethics committee address [5] 1354 0
Ethics committee country [5] 1354 0
Australia
Date submitted for ethics approval [5] 1354 0
Approval date [5] 1354 0
Ethics approval number [5] 1354 0
Ethics committee name [6] 1355 0
Northern Hospital
Ethics committee address [6] 1355 0
Ethics committee country [6] 1355 0
Australia
Date submitted for ethics approval [6] 1355 0
Approval date [6] 1355 0
Ethics approval number [6] 1355 0

Summary
Brief summary
This study examines the effects of paramedic cooling using large-voulme, ice-cold intravenous fluid in comatose survivors of out-of-hospital cardiac arrest, compared with standard care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35758 0
Address 35758 0
Country 35758 0
Phone 35758 0
Fax 35758 0
Email 35758 0
Contact person for public queries
Name 9387 0
Dr Stephen Bernard
Address 9387 0
Central and Eastern Clinical School
Alfred Hospital
Melbourne VIC 3004
Country 9387 0
Australia
Phone 9387 0
+61 419303737
Fax 9387 0
Email 9387 0
[email protected]
Contact person for scientific queries
Name 315 0
Dr Stephen Bernard
Address 315 0
Central and Eastern Clinical School
Alfred Hospital
Melbourne VIC 3004
Country 315 0
Australia
Phone 315 0
+61 419303737
Fax 315 0
Email 315 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.