ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620000913976p

Ethics application status

Submitted, not yet approved

Date submitted

18/07/2020

Date registered

16/09/2020

Date last updated

16/09/2020

Date data sharing statement initially provided

16/09/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Prevalence of Hypomagnesaemia after Major Abdominal Surgery (Magmas-I Study)

Scientific title

Observational study to investigate the prevalence of hypomagnesaemia in patients undergoing major abdominal surgery (Magmas-I Study),

Secondary ID [1]

none

Universal Trial Number (UTN)

U1111-1255-6747

Trial acronym

MAGMAS

Linked study record

Health condition

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

magnesium deficiency

hypomagnesemia post major abdominal surgery

Condition category

Condition code

Surgery

Other surgery

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Participants' magnesium levels are routinely measured as part of standard medical care before and after major abdominal surgery.
Before the surgery when patients attend the pre-admission clinic, blood will be drawn at the clinic for the routine preoperative blood tests, among which, one serum magnesium level is measured, which will be used as a baseline value for that particular patient. Of note, a single baseline serum magnesium level, through the routine preoperative blood tests, of no more than 10 mL blood will be drawn from the patient.
After the surgery, routine postoperative blood tests will usually be performed on the next morning after operation, i.e., postoperative day-1, among these routine blood test, the second serum magnesium level is measured, which will be used to compare with that participant's baseline serum magnesium level. Of note, a single serum magnesium level, through the routine preoperative blood tests, of no more than 10 mL blood will be drawn from the patient.
As such, the total duration from before to after major abdominal surgery during the assessment of serum magnesium levels is 2 days.

Intervention code [1]

Early Detection / Screening

Comparator / control treatment

Using patients' serum magnesium levels before major abdominal surgery as the reference values, patients' serum magnesium levels after major abdominal surgery will compare with their respective reference values.

Control group

Active

Outcomes

Primary outcome [1]

To establish a baseline prevalence of hypomagnesemia before and after major abdominal surgery:
Normal serum magnesium levels are between 1.8 and 2.2 mg/dL. Hypomagnesemia is an electrolyte disturbance caused when there is a low level of serum magnesium (less than 1.8 mg/dL) in the blood.
Through the routine preoperative blood tests, preoperative and postoperative day-1 serum magnesium levels will be measured. These results will be accessed from the hospital electronic medical records.
The prevalence will be calculated by the percentage of patients whose magnesium levels are lower than 1.8 mg/dL. Since this is observational study, i.e., no intervention or treatment, this prevalence is a baseline.

Timepoint [1]

preoperative blood tests are usually performed when the patients attend the pre-admission clinic;
postoperative blood tests will be performed on the next morning after surgery, i.e., postoperative day-1
approximately two days in total from pre-operation to postoperative day-1

Secondary outcome [1]

To determine the prevalence of severe hypomagnesemia before and after major abdominal surgery:
hypomagnesemia is defined as the serum magnesium lower than 1.8 mg/dL;
severe hypomagnesemia is defined as magnesium level below 1.25 mg/dL.
blood tests will be performed before and after surgery, data on serum magnesium results will be collected from the hospital electronic medical records.
the percentage of patients whose magnesium levels are lower than 1.25 mg/dL will be calculated, and the prevalence of severe hypomanesemia is thus determined.

Timepoint [1]

Eligibility

Key inclusion criteria

Inclusions (must meet all of the following three criteria):
1. Adult patients undergoing elective laparoscopic or open abdominal surgery at Angliss Hospital and Maroondah Hospital, Eastern Health
2. Surgery must last more than two hours
3. Patients must stay in the hospital for more than one night

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusions:
1. Patient refusal
2. younger than 18 years old
3. Language barrier
4. Intellectual disability or dementia

Study design

Purpose

Screening

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

paired t test and descriptive statistics

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/01/2021

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Maroondah Hospital - Ringwood East

Recruitment postcode(s) [1]

3135 - Ringwood East

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Maroondah Hospital

Address [1]

1-15 Davey Drive
East Ringwood
VIC 3135

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Aihua Wu

Address

Department of Anaesthesia
Maroondah Hospital
1-15 Davey Drive
East Ringwood
VIC 3135

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Maroondah Hospital

Address [1]

1-15 Davey Drive
East Ringwood
VIC 3135

Country [1]

Australia

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Eastern Health Human Research Ethics Committee

Ethics committee address [1]

Level 2
The Office of Research and Ethics
5 Arnold Street
Box Hill 
VIC 3128

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/06/2020

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Magnesium is an essential macronutrient that exists in every human cell for the body to function, it plays a vital role in many body processes, including muscle (like heart muscles), nerve, bone health and mood. As such, inadequate magnesium in the body can cause a range of medical conditions and complications.
While many studies have been carried out in the intensive care setting, reporting that magnesium deficiency is prevalent in those critically ill patients, few studies have investigated this problem after major abdominal surgery. However, in practice, low magnesium is often seen after a major abdominal operation, in particular bowel surgery, as such, some doctors may empirically prescribe magnesium for patients undergoing these procedures.
Given that magnesium is readily available and easy to administer, there is an urgent need to know how bad the postoperative deficiency is so that correction can be made in a timely manner.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr aihua wu

Address

Department of Anaesthesia and Pain Management
Maroondah Hospital
1-15 Davey Drive,
Ringwood East
VIC 3135

Country

Australia

Phone

+61398713448

Fax

aihua.wu@easternhealth.org.au

Contact person for public queries

Name

aihua wu

Address

Department of Anaesthesia and Pain Management
Maroondah Hospital
1-15 Davey Drive,
Ringwood East
VIC 3135

Country

Australia

Phone

+61398713448

Fax

aihua.wu@easternhealth.org.au

Contact person for scientific queries

Name

aihua wu

Address

Department of Anaesthesia and Pain Management
Maroondah Hospital
1-15 Davey Drive,
Ringwood East
VIC 3135

Country

Australia

Phone

+61398713448

Fax

aihua.wu@easternhealth.org.au

Data sharing statement

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

Yes

What data in particular will be shared?

All of the individual participant data collected during the trial, which are de-identified.

When will data be available (start and end dates)?

Immediately following publication. No end date.

Available to whom?

Anyone who wishes to access the data

Available for what types of analyses?

Any purpose.

How or where can data be obtained?

Data are available indefinitely by emailing the principal investigator Dr Aihua Wu at aihua.wu@easternhealth.org.au

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
8538	Informed consent form			aihua.wu@easternhealth.org.au		380222-(Uploaded-18-07-2020-11-00-32)-Study-related document.pdf

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.

Trial Review

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