Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000282987
Ethics application status
Approved
Date submitted
15/03/2011
Date registered
17/03/2011
Date last updated
17/03/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Emergency Department Anaphylaxis Trial II B - preliminary trial to confim pharmacokinetic profiles and study feasibility in patients with anaphylaxis treated with either intramuscular vs. intavenous adrenaline
Scientific title
Randomisation of patients with anaphylaxis to either intramuscular vs. intravenous adrenaline - preliminary trial to confirm pharmacokinetic profiles and study feasibility of a composite endpoint
Secondary ID [1] 259781 0
Nil
Universal Trial Number (UTN)
Trial acronym
EDAIIb
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaphylaxis 261363 0
Condition category
Condition code
Inflammatory and Immune System 259523 259523 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparision of standard intramuscular adrenaline (0.01 mg/kg to a maximum of 0.5 mg - repeated once at 5-10 minutes as required) vs. intravenous infusion (1:100,000) titrated to effect (starting at 0.5 mls/kg/hr or 1.0 mls/kg/hr if hypotensive) in the initial management of patients with ananphylaxis
Intervention code [1] 264214 0
Treatment: Drugs
Comparator / control treatment
Intramuscular adrenaline is deemed to be the control group.
Control group
Active

Outcomes
Primary outcome [1] 262323 0
The primary clinical endpoint will be resolution of main clinical features (defined by absence of the feature or improvement by at least 2 points on the ordinal severity scale) at 15 minutes.
Timepoint [1] 262323 0
15 minutes
Secondary outcome [1] 273542 0
The two groups will be compared for adverse effects such as myocardial ischaemia, myocardial infarction, hypertension and intracerebral haemorrhage. This will assessed via direct questioning, clinical assessment and continuous monitoring of ECG and Blood pressure
Timepoint [1] 273542 0
15 and 60 minutes

Eligibility
Key inclusion criteria
Any acute onset (minutes-hours) illness with typical skin features (generalised hives, pruritus or flushing, swollen lips &/or tongue), PLUS involvement of at least one other organ system (respiratory, cardiovascular, gastrointestinal)

-OR-

Any acute onset (minutes-hours) of hypotension or bronchospasm where anaphylaxis is considered possible, even if the typical skin features listed above are not present.
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
14 years of age or less

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)
Patients presenting to Emergency Departments of participating hospitals. Sealed randomisation envelope held in ED.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocations generated using a random number table with a 2:1 ratio (iv to im).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 3302 0
New Zealand
State/province [1] 3302 0

Funding & Sponsors
Funding source category [1] 264661 0
Charities/Societies/Foundations
Name [1] 264661 0
Hawkes Bay Medical Research Foundation
Country [1] 264661 0
New Zealand
Primary sponsor type
Individual
Name
Dr Craig Ellis
Address
Centre for Clinical Research in Emergency Medicine
West Australian Medical Research Institute
Royal Perth Hospital
Wellington Road
Perth 6001
Country
Australia
Secondary sponsor category [1] 263799 0
University
Name [1] 263799 0
Professor Simon Brown
Address [1] 263799 0
Centre for Clinical Research in Emergency Medicine
West Australian Medical Research Institute
Royal Perth Hospital
Wellington Road
Perth 6001
Country [1] 263799 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266656 0
Royal Perth Hospital
Ethics committee address [1] 266656 0
Ethics Committee,
Royal Perth Hospital
Wellington Road
Perth 6001
Ethics committee country [1] 266656 0
New Zealand
Date submitted for ethics approval [1] 266656 0
25/08/2010
Approval date [1] 266656 0
Ethics approval number [1] 266656 0
RPH EC 2010/085

Summary
Brief summary
Anaphylaxis is a severe potentially life-threatening allergic reaction. The accepted management is intramuscular adrenaline. With intravenous adrenaline being a last resort therapy. The investigators believe that intravenous adrenaline given slowly as a dilute infusion is a better therapy, with more rapid onset (especially in patients with low blood pressure) with a similar side-effect profile to intramuscular adrenaline. This study is part of a wider PhD assessing this hypothesis and also the pharmacological behaviour of adrenaline.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32343 0
Address 32343 0
Country 32343 0
Phone 32343 0
Fax 32343 0
Email 32343 0
Contact person for public queries
Name 15590 0
Dr Craig Ellis
Address 15590 0
c/o Emergency Department
Hawkes Bay Regional Hospital
Canning Road
Hastings
New Zealand 4120
Country 15590 0
New Zealand
Phone 15590 0
+64-27-2340063
Fax 15590 0
Email 15590 0
craig.ellis@hawkesbaydhb.govt.nz
Contact person for scientific queries
Name 6518 0
Dr Craig Ellis
Address 6518 0
c/o Emergency Department
Hawkes Bay Regional Hospital
Canning Road
Hastings
New Zealand 4120
Country 6518 0
New Zealand
Phone 6518 0
+64-27-2340063
Fax 6518 0
Email 6518 0
craig.ellis@hawkesbaydhb.govt.nz

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
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Documents added automatically
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