Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000925145
Ethics application status
Approved
Date submitted
20/06/2019
Date registered
3/07/2019
Date last updated
3/11/2020
Date data sharing statement initially provided
3/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Magnesium supplementation in mechanical ventilated critically ill adult patients
Scientific title
The pharmacokinetics of magnesium supplementation in mechanically ventilated adult critical care patients
Secondary ID [1] 298546 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Electrolyte supplementation 313368 0
Condition category
Condition code
Metabolic and Endocrine 311811 311811 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Administration of intravenous 10 mmol bolus of magnesium sulphate over 1 hour followed by a continues magnesium infusion of 1.5-3.0 mmol/hr to maintain serum magnesium levels between 1.5 - 2.0 mmol/L until intensive care unit discharge
Intervention code [1] 314801 0
Treatment: Drugs
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320480 0
Concentration of serum magnesium
Timepoint [1] 320480 0
Serum measured concentration of magnesium from baseline at 1 hour and then 6 hourly until end of infusion which will be at the time of intensive care unit discharge
Secondary outcome [1] 371770 0
Rate of renal magnesium excretion
Timepoint [1] 371770 0
Urinary measured concentration of magnesium from baseline at 1 hour and then 6 hourly until end of infusion which will be at the time of intensive care unit discharge.

Eligibility
Key inclusion criteria
Admitted to the intensive care unit
aged equal to or greater than 18 years
existing intra-arterial catheter
existing central venous catheter
existing indwelling urinary catheter
mechanically ventilated via an endotracehael tube
receiving vasopressor supportive therapy
treating clinician decides that intravenous magnesium replacement is necessary
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
admission following cardiac surgery
allergy to magnesium sulphate or one of its excipients
pregnancy
already receiving or had received a continuous intravenous magenesium infusion in the previous 24 hours
currently receiving a muscle relaxant infusion
at the time of screening has a serum creatinine concentration of greater than 200 micrommol/L
at the time of screening is receiving renal replacement therapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Along with simple descriptive statistics, continuous variables will be expressed as either mean (SD) or median (IQR) and categorical variables were expressed as n (%). Difference in measurements before and after drug administration will be compared using paired t-test with a two-sided P-value <0.05 considered statistically significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/07/2019
Actual
16/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
27
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14028 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 26818 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 303093 0
Hospital
Name [1] 303093 0
Austin Hospital
Country [1] 303093 0
Australia
Primary sponsor type
Hospital
Name
Austin Hospital
Address
Austin Health
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 303080 0
Individual
Name [1] 303080 0
Professor Rinaldo Bellomo
Address [1] 303080 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Country [1] 303080 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303637 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 303637 0
Ethics committee country [1] 303637 0
Australia
Date submitted for ethics approval [1] 303637 0
22/03/2019
Approval date [1] 303637 0
18/06/2019
Ethics approval number [1] 303637 0
HREC/52758/Austin-2019

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

Contacts
Principal investigator
Name 94350 0
Prof Rinaldo Bellomo
Address 94350 0
Professor Rinaldo Bellomo
Director Intensive Care Research
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Country 94350 0
Australia
Phone 94350 0
+61 3 9496 5992
Fax 94350 0
+61 3 9496 3932
Email 94350 0
[email protected]
Contact person for public queries
Name 94351 0
Rinaldo Bellomo
Address 94351 0
Professor Rinaldo Bellomo
Director Intensive Care Research
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Country 94351 0
Australia
Phone 94351 0
+61 3 9496 5992
Fax 94351 0
+61 3 9496 3932
Email 94351 0
[email protected]
Contact person for scientific queries
Name 94352 0
Rinaldo Bellomo
Address 94352 0
Professor Rinaldo Bellomo
Director Intensive Care Research
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Country 94352 0
Australia
Phone 94352 0
+61 3 9496 5992
Fax 94352 0
+61 3 9496 3932
Email 94352 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


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.