Trial Review

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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] 301819 0
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 318294 0
hypomagnesemia post major abdominal surgery 318295 0
Condition category
Condition code
Surgery 316306 316306 0 0
Other surgery
Oral and Gastrointestinal 316623 316623 0 0
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] 318118 0
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] 324479 0
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] 324479 0
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] 384772 0
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] 384772 0
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

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?
No
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] 17115 0
Maroondah Hospital - Ringwood East
Recruitment postcode(s) [1] 30791 0
3135 - Ringwood East

Funding & Sponsors
Funding source category [1] 306246 0
Hospital
Name [1] 306246 0
Maroondah Hospital
Country [1] 306246 0
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] 306972 0
Hospital
Name [1] 306972 0
Maroondah Hospital
Address [1] 306972 0
1-15 Davey Drive
East Ringwood
VIC 3135
Country [1] 306972 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306456 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 306456 0
Level 2
The Office of Research and Ethics
5 Arnold Street
Box Hill
VIC 3128
Ethics committee country [1] 306456 0
Australia
Date submitted for ethics approval [1] 306456 0
22/06/2020
Approval date [1] 306456 0
Ethics approval number [1] 306456 0

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 103946 0
Dr aihua wu
Address 103946 0
Department of Anaesthesia and Pain Management
Maroondah Hospital
1-15 Davey Drive,
Ringwood East
VIC 3135
Country 103946 0
Australia
Phone 103946 0
+61398713448
Fax 103946 0
Email 103946 0
aihua.wu@easternhealth.org.au
Contact person for public queries
Name 103947 0
aihua wu
Address 103947 0
Department of Anaesthesia and Pain Management
Maroondah Hospital
1-15 Davey Drive,
Ringwood East
VIC 3135
Country 103947 0
Australia
Phone 103947 0
+61398713448
Fax 103947 0
Email 103947 0
aihua.wu@easternhealth.org.au
Contact person for scientific queries
Name 103948 0
aihua wu
Address 103948 0
Department of Anaesthesia and Pain Management
Maroondah Hospital
1-15 Davey Drive,
Ringwood East
VIC 3135
Country 103948 0
Australia
Phone 103948 0
+61398713448
Fax 103948 0
Email 103948 0
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.TypeCitationLinkEmailOther DetailsAttachment
8538Informed 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.