ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617001263381

Ethics application status

Approved

Date submitted

25/08/2017

Date registered

1/09/2017

Date last updated

13/12/2018

Date data sharing statement initially provided

13/12/2018

Date results provided

13/12/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Magnesium after cardiac surgery practice change audit

Scientific title

An audit of a change in the intensive care unit magnesium administration protocol in patients following cardiac surgery: effect on occurrence of atrial fibrillation

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

Trial acronym

MAGIC IV

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Electrolyte disturbance

Cardiovascular disease

CARDIAC SURGERY

Condition category

Condition code

Cardiovascular

Coronary heart disease

Surgery

Other surgery

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

From 1st October 2017 until 31st March 2018, for all cardiac surgical patients at admission to the ICU following surgery, a loading dose of 10 mmol of magnesium sulphate diluted in 100 mL of saline will be administered intravenously over the period of 1 hour. After the end of the loading dose, a continuous infusion of magnesium sulphate will be commenced at a rate of 3 mmol/h (total extrapolated dose over 24 hours of 82 mmol). The continuous infusion will be maintained during the first 96 hours of ICU stay or until ICU discharge, whichever occurs first; and we will aim a serum magnesium concentration between 1.5 and 2.0 mmol/L with magnesium level monitoring twice daily.

Intervention code [1]

Not applicable

Comparator / control treatment

From 1st October 2016 until the 31st March 2017, for all cardiac surgical patients admitted to the ICU we will retrospectively collected data for their medical record

Control group

Historical

Outcomes

Primary outcome [1]

Occurrence of atrial fibrillation - hospital stay

Timepoint [1]

As documented in the patient's medical record as assessed from the time of admission to the intensive care unit through to discharge from the hospital

Primary outcome [2]

Occurrence of atrial fibrillation - Intensive care unit admission

Timepoint [2]

As documented in the patient's medical record as assessed from the time of admission to the intensive care unit through to discharge from the intensive care unit

Secondary outcome [1]

Duration of intensive care unit admisison

Timepoint [1]

Number of days that patient is admitted to the intensive care unit following cardiac surgery.

Secondary outcome [2]

Duration of hospital admission

Timepoint [2]

Number of days that patient is admitted to the hospital following cardiac surgery.

Secondary outcome [3]

Duration of mechanical ventilation

Timepoint [3]

The total number of hours of mechanical ventilation in the intensive care unit following cardiac surgery.

Secondary outcome [4]

Mean serum magnesium concentration

Timepoint [4]

Mean serum magnesium concentration of the routine morning formal blood test during admission to intensive care

Secondary outcome [5]

Dose of magnesium sulphate administered

Timepoint [5]

Total amount in mmol/L of magnesium sulphate administered to post-cardiac surgery patients during the intensive care admission

Eligibility

Key inclusion criteria

Adult (aged 18 years or older) patients who are admitted to the intensive care unit following cardiac surgery.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

- known renal impairment
- treating intensive care unit consultant feels that it is not in the patient's best interest to be treated with the new magnesium supplementation protocol

Study design

Purpose

Natural history

Duration

Cross-sectional

Selection

Convenience sample

Timing

Both

Statistical methods / analysis

We will apply descriptive and inferential statistical procedures to the data collected for the purposes of this audit. Baseline comparisons will be performed using Fisher’s exact tests and reported as n (%). Continuous normally distributed variables will be compared using Student t-tests and reported as means (standard deviation), while non-normally distributed data will be compared using Wilcoxon rank-sum tests and reported as medians [interquartile range]. Changes over time will be determined using repeated measures mixed linear modeling with each patient treated as a random effect, and therapy group, time and the interaction of therapy group and time as effect fixed effects.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/10/2017

Actual

25/09/2017

Date of last participant enrolment

Anticipated

Actual

27/10/2017

Date of last data collection

Anticipated

Actual

30/11/2017

Sample size

Target

200

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Austin Health - Austin Hospital - Heidelberg

Recruitment postcode(s) [1]

3084 - Heidelberg

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Austin Hospital

Address [1]

145 Studley Road
Heidelberg VIC 3084

Country [1]

Australia

Primary sponsor type

Hospital

Name

Austin Health

Address

145 Studley Road
Heidelberg VIC 3084

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Professor Rinaldo Bellomo

Address [1]

Director, Intensive Care Research
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg, VIC 3084

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee

Ethics committee address [1]

Austin Hospital
145 Studley Road
Heidelberg VIC 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/08/2017

Approval date [1]

22/08/2017

Ethics approval number [1]

LNR/17/Austin/416

Summary

Brief summary

Atrial fibrillation (AF) is the most common complication after cardiac surgery, with an incidence ranging from 20 to 50%. It represents a potential cause of thromboembolic events, hemodynamic instability and prolonged Intensive Care Unit (ICU) stay. Maintaining a normal blood magnesium concentration may help prevent the onset of atrial fibrillation after cardiac surgery.  

Previously we performed an assessment of the pharmacokinetics of magnesium administration after cardiothoracic surgery from August, 2016 to April, 2017: “Assessment of Blood and Urine Magnesium Levels in Patients Admitted to the Intensive Care Unit” (HREC: LNR/15/Austin/306). We included  60 patients: 30 patients in the before period who received a bolus of 20 mmol of magnesium sulphate over 1 hour; and 30 patients in the after period who received a bolus of 10 mmol of magnesium sulphate followed by a continuous infusion at 3 mmol/h over 12 hours. In the before period, we found that the loading dose of 20 mmol increased both serum and urinary magnesium concentrations, however the serum concentration returned to pre-intervention levels within 12 hours of observation and the urinary excretion remained elevated. In the after period, the intervention of a loading dose of 10 mmol of magnesium sulphate followed by a continuous infusion was associated with an increase of both the serum and urinary concentrations of magnesium over time. The after-period protocol allowed us to achieve a sustained, safe, and moderately elevated serum magnesium concentration at twice to three times the lowest total magnesium concentration in our laboratory (1.4 to 2.0 mmol/L), which might be expected to deliver a greater chance of AF prevention.  As such the management practices associated with magnesium administration in our intensive care unit has changed.  The purpose of this project is to evaluate the effect of the new protocol on the incidence of atrial fibrillation in patients who undergo cardiac surgery and are admitted to the intensive care unit.  Using a medical record audit design we will evaluate patients treated with the new magnesium protocol with that of a historical control.

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/373534-20170822 LETTER LNR17Austin416 Ethics New Study Approval (Audit).pdf (Ethics approval)

Contacts

Principal investigator

Name

Prof Rinaldo Bellomo

Address

Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084

Country

Australia

Phone

+61 3 9496 5992

Fax

+61 3 9496 3932

rinaldo.bellomo@austin.org.au

Contact person for public queries

Name

Glenn Eastwood

Address

Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084

Country

Australia

Phone

+61 3 9496 4835

Fax

+61 3 9496 3932

glenn.eastwood@austin.org.au

Contact person for scientific queries

Name

Rinaldo Bellomo

Address

Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084

Country

Australia

Phone

+61 3 9496 4835

Fax

+61 3 9496 3932

rinaldo.bellomo@austin.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

pilot single centre investigation with the aim of providing preliminary safety data and only be hypothesis generating.

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Critical Care and Resuscitation • Volume 20 Number... [More Details]
Plain language summary	No		The strategy of a 10 mmol magnesium bolus followed... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Continuous Magnesium Infusion to Prevent Atrial Fibrillation After Cardiac Surgery: A Sequential Matched Case-Controlled Pilot Study.	2020	https://dx.doi.org/10.1053/j.jvca.2020.04.006

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically