Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000838819
Ethics application status
Approved
Date submitted
26/07/2012
Date registered
9/08/2012
Date last updated
5/06/2019
Date data sharing statement initially provided
5/06/2019
Date results information initially provided
5/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does magnesium sulphate reduce length of stay and improve spirometry in acute moderate to severe asthma when initial treatment fails?
Scientific title
Adults with acute asthma non responsive to initial treatment treated with intravenous magnesium sulphate versus placebo as an adjunct to standard care;the effect on lung function and length of stay in hospital.
Secondary ID [1] 280916 0
There are no secondary IDs
Universal Trial Number (UTN)
U1111-1132-9821
Trial acronym
ASsesing THe use of Magnesium in Asthma

ASTHMA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
asthma 286997 0
Condition category
Condition code
Respiratory 287330 287330 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravenous magnesium sulphate as a single dose of 20mmol in 100mls normal saline as a slow infusion over 30-40 minutes
In addition to standard care/treatment 3x5mg nebulizations of salbutamol and 1x500mcg nebulization of atrovent and 50mg oral prednisolone.
Further salbutamol 5mg nebulizations as required prn for the next 4 hours ( duration of the trial intervention protocol) After this time patient is either discharged or admitted and treatment is determined by the admitting clinician according to need.

Standard care with nebulizations and oral prednisolone given first then if eligible for the trial then given magnesium suplate or placebo and additional ventolin nebulizations as required for the duration of the intervention (4hours)
Intervention code [1] 285352 0
Treatment: Drugs
Comparator / control treatment
Placebo as normal saline 100mls in addition to standard care/treatment as described above.
Control group
Placebo

Outcomes
Primary outcome [1] 287602 0
discharge from hospital
Timepoint [1] 287602 0
4 hours post intervention ( treatment with magnesium)
Primary outcome [2] 287603 0
total duration of stay in hospital in hours
Timepoint [2] 287603 0
from time of enrollment to discharge from hospital
Secondary outcome [1] 298514 0
Improvement in lung function as measured by spirometry
Timepoint [1] 298514 0
4 hours post intervention and at followup 72 hours post intervention
Secondary outcome [2] 298515 0
withdrawl from trial
Timepoint [2] 298515 0
at any time from enrolment to 4 hours post intervention
Secondary outcome [3] 298516 0
need for admission to intensive care
Timepoint [3] 298516 0
from time of enrollment to discharge from hospital
Secondary outcome [4] 298517 0
need for invasive or non invasive ventilation
Timepoint [4] 298517 0
from time of enrollment to discharge from hospital

Eligibility
Key inclusion criteria
Acute asthma exacerbation requiring attendance to an emergency department
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
life threatening asthma
pregnancy
other respiratory diseases eg pulmonary embolis,pneumonia

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)
Allocation by pharmacy numerical ordering. Numbered plain containers for drug and placebo.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by pharmacy via computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2012
Actual
1/06/2012
Date of last participant enrolment
Anticipated
Actual
1/09/2017
Date of last data collection
Anticipated
Actual
1/09/2017
Sample size
Target
320
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 285785 0
Self funded/Unfunded
Name [1] 285785 0
Country [1] 285785 0
Primary sponsor type
Individual
Name
maureen busuttil
Address
c/o lyell mcewin emergency department
lyell mcewin hospital
haydown rd
elizabeth vale SA 5112
Country
Australia
Secondary sponsor category [1] 284528 0
Individual
Name [1] 284528 0
vicki clifton
Address [1] 284528 0
c/o The robinson institute
lyell mcewin hospital
haydown rd
elizabeth vale SA 5112
Country [1] 284528 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287697 0
Ethics of Human Research Committee
Ethics committee address [1] 287697 0
The Queen Elizabeth Hospital
28 Woodville Rd
Woodville South SA 5011
and
Lyell Mcewin Hospital
Haydown Rd
ElizabethVale SA 5112

This is the Same committee but has offices at both campuses. This is how the address appears on their correspondence
Ethics committee country [1] 287697 0
Australia
Date submitted for ethics approval [1] 287697 0
22/04/2010
Approval date [1] 287697 0
27/09/2010
Ethics approval number [1] 287697 0
2010076

Summary
Brief summary
To ascertain whether the addition of intravenous magnesium sulphate for treatment of acute asthma exacerbations where standard treatment has failed to resolve the attack will improve outcomes and reduce the need for admission to hospital
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34488 0
Dr Maureen Busuttil
Address 34488 0
c/o Emergency Department
Lyell McEwin Health Service
Haydown Rd
Elizabeth Vale SA 5112
Country 34488 0
Australia
Phone 34488 0
+61448839014
Fax 34488 0
Email 34488 0
[email protected]
Contact person for public queries
Name 17735 0
Dr maureen busuttil
Address 17735 0
Emergency department
lyell mcewin hospital
haydown rd
elizabeth vale SA 5112
Country 17735 0
Australia
Phone 17735 0
+61 8 81829279
Fax 17735 0
Email 17735 0
[email protected]
Contact person for scientific queries
Name 8663 0
Dr maureen busuttil
Address 8663 0
robinson institute
lyell mcewin hospital
haydown rd
elizabeth vale SA 5112
Country 8663 0
Australia
Phone 8663 0
+61 8 81332133
Fax 8663 0
Email 8663 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
de-identified data ie results are available upon request
study protocol, informed consent form and study report are available upon request


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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