Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000837729
Ethics application status
Approved
Date submitted
25/07/2013
Date registered
30/07/2013
Date last updated
5/03/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intravenous magnesium as an adjunct treatment in acute exacerbations of chronic obstructive pulmonary disease.
Scientific title
Intravenous magnesium sulphate will improve bronchodilation in patients with acute exacerbations of chronic obstructive pulmonary disease (COPD) compared to placebo.
Secondary ID [1] 282909 0
Nil
Universal Trial Number (UTN)
U1111-1141-6451
Trial acronym
MAGIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute exacerbations of COPD 289721 0
Condition category
Condition code
Respiratory 290048 290048 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravenous magnesium sulphate 2 mmols diluted in 15mls of saline, administerered over 15minutes via infusion pump. This will be done only once. Patients will be followed up upto 2 hours post administration. Length of stay and outcome data will be collected after 1 month.
Intervention code [1] 287605 0
Treatment: Drugs
Comparator / control treatment
Saline solution 15mls administered over 15minutes
Control group
Placebo

Outcomes
Primary outcome [1] 290100 0
FEV1 following treatment. This will be measured using bedside spirometry carried out be trained staff.
Timepoint [1] 290100 0
FEV1 measurements at 0, 60, 120minutes
Secondary outcome [1] 303945 0
length of stay
Timepoint [1] 303945 0
Length of stay data will be collected 1 month post trial drug administration.
Secondary outcome [2] 303968 0
Need for NIV or mechanical ventillation.
Timepoint [2] 303968 0
Assessed hourly by the trial team as well as on an Ad Hoc basis by the medical team.

Eligibility
Key inclusion criteria
Known previous diagnosis of COPD, presented to ED with a primary diagnosis of acute exacerbation of COPD.
Minimum age
35 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Anyone deemed to require immediate NIV or mechanical ventilation on presentation.
Patients who are unable to carry out spirometry.
Other active problems that may be life threatening.
Hypotension.
Pregnancy.

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)
Eligible patients will be approached by members of the trial team and if agreeable by the patient, will be consented for the trial.
Randomisation and allocation will be masked to the trial staff, medical team and the patient.
Randomisation and allocation will be carried out using block randomisation by pharmacy. Numbered syringes will be provided which the trial member will use, and inform pharmacy of the syringe number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A proposed sample of 160 patients is estimated following a power calculation using previous trials as a guideline [Skorodin et al, 1995; Hughes et al, 2003; Gonzalez et al, 2006]. To detect an absolute difference in FEV1 of 0.30L with at least 80% power and an alpha error level of 5%, 80 participants were required in each treatment arm.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2013
Actual
1/07/2013
Date of last participant enrolment
Anticipated
30/11/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment outside Australia
Country [1] 5248 0
New Zealand
State/province [1] 5248 0
Manawatu

Funding & Sponsors
Funding source category [1] 287687 0
Self funded/Unfunded
Name [1] 287687 0
Country [1] 287687 0
New Zealand
Primary sponsor type
Individual
Name
Saptarshi Mukerji
Address
Intensive care Unit
Palmerston North Hospital
Ruahine street
Roslyn
Palmerston North
4414
Country
New Zealand
Secondary sponsor category [1] 286420 0
None
Name [1] 286420 0
Address [1] 286420 0
Country [1] 286420 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289646 0
Health and Disability Ethics Committee
Ethics committee address [1] 289646 0
Ethics committee country [1] 289646 0
New Zealand
Date submitted for ethics approval [1] 289646 0
22/05/2013
Approval date [1] 289646 0
19/06/2013
Ethics approval number [1] 289646 0
13/NTA/58

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

Contacts
Principal investigator
Name 41758 0
Dr Saptarshi Mukerji
Address 41758 0
Intensive care Unit
Palmerston North Hospital
Ruahine street
Palmerston north
4414
Country 41758 0
New Zealand
Phone 41758 0
+64223128766
Fax 41758 0
Email 41758 0
sapimukerji@doctors.org.uk
Contact person for public queries
Name 41759 0
Saptarshi Mukerji
Address 41759 0
Intensive care Unit
Palmerston North Hospital
Ruahine street
Palmerston north
4414
Country 41759 0
New Zealand
Phone 41759 0
+64223128766
Fax 41759 0
Email 41759 0
sapimukerji@doctors.org.uk
Contact person for scientific queries
Name 41760 0
Saptarshi Mukerji
Address 41760 0
Intensive care Unit
Palmerston North Hospital
Ruahine street
Palmerston north
4414
Country 41760 0
New Zealand
Phone 41760 0
+64223128766
Fax 41760 0
Email 41760 0
sapimukerji@doctors.org.uk

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
EmbaseIntravenous magnesium sulphate as an adjuvant therapy in acute exacerbations of chronic obstructive pulmonary disease: A single centre, randomised, double-blinded, parallel group, placebocontrolled trial: A pilot study.2015
N.B. These documents automatically identified may not have been verified by the study sponsor.