RecruitingPHASE4INTERVENTIONAL

Effect of Protocolized Magnesium Replacement on Mortality and Atrial Fibrillation in Critically Ill Patients

This study focuses on critically ill patients in intensive care units (ICUs), such as those with severe infections or heart problems. In ICUs, patients often receive magnesium to keep their levels healthy, but doctors aren’t sure what the ideal magnesium level should be. This trial compares two different ways of giving magnesium: one aiming for a slightly higher level and another for a slightly lower level. The main goal is to see if one approach helps patients live longer (for at least 30 days) and reduces their chances of developing an irregular heartbeat called atrial fibrillation. Patients in the study won't need extra tests or tasks; their care will continue as normal while doctors monitor their magnesium levels and health outcomes.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Scarborough General Hospital

Enrolment target

3,253

Start

25 Nov 2025

Estimated completion

01 Jun 2027

Critical Illness

What is this study about?

When people are very seriously ill, for example, with a severe infection, a heart attack, or breathing problems, they often need to be looked after in an intensive care unit (ICU). In the ICU, doctors and nurses carefully monitor many things, including the levels of important minerals in the body, like magnesium. Magnesium is really important for many body functions, including your heart and nerves.

Currently, ICUs regularly measure magnesium levels and give extra magnesium if levels are too low. However, doctors aren't completely sure what the 'best' magnesium level is for critically ill patients. This study aims to find out if keeping magnesium levels slightly higher or slightly lower makes a difference to how well patients recover. They will compare two different approaches to giving magnesium, both of which are considered safe and standard care.

The main things the study wants to understand are: Does one approach to giving magnesium lead to more patients surviving for at least 30 days after their illness? And does it reduce the chance of patients developing an irregular heartbeat called atrial fibrillation? This research is important because it could help improve the care of very sick patients in the future.

Key takeaways

The study looks at how magnesium levels are managed in very ill patients.
It compares two standard ways of giving magnesium in intensive care.
The goal is to improve survival and reduce irregular heartbeats.
Participation won't involve extra tests or duties for the patient.
Both magnesium approaches are already part of standard care.

Who may be eligible?

To be able to join this study, you would need to be at least 16 years old. You would also need to have been admitted to a medical-surgical intensive care unit (ICU) and your doctors would have decided that you need a magnesium replacement plan as part of your care.

There are a few reasons why someone might not be able to join the study. For instance, if you have a specific type of sustained irregular heartbeat called ventricular tachycardia, or if you have a condition called pre-eclampsia (which usually affects pregnant women), you wouldn't be eligible. Also, if you have a rare condition affecting your muscles called myasthenia gravis, you couldn't take part. If you've been part of an earlier magnesium study called MAGNOLIA, you also wouldn't be able to join this one.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 16 years old or older?
Are you currently admitted to an intensive care unit?
Has your doctor ordered magnesium treatment for you?
Do you *not* have a specific type of irregular heartbeat (sustained ventricular tachycardia)?
Do you *not* have pre-eclampsia or myasthenia gravis?

Answer every question to see your result.

What does participation involve?

If you are eligible and your doctor decides you should be part of the study, this research will be integrated into your normal medical care in the intensive care unit (ICU). You won't have to do anything extra, like fill out questionnaires, attend additional appointments, or undergo any special tests apart from those already planned for your treatment. The nurses and doctors will continue to monitor your magnesium levels and other health information as part of your routine care, and this data will be safely used for the study. Your participation will last for at least 30 days, as researchers will be looking at your health outcomes during this period.

Potential risks and benefits

Taking part in this study means your magnesium levels will be managed using one of two common approaches. Since both approaches are considered standard care, there are no expected additional risks from participating. The potential benefit is that the study will help doctors understand the best way to give magnesium to critically ill patients, which could improve care for everyone in the future. You always have the right to withdraw from the study at any time without it affecting your medical care.

Locations (6)

Lakeridge Health Ajax-Pickering
Verified postcode
Ajax, Canada· Recruiting
Lakeridge Health Bowmanville
Verified postcode
Bowmanville, Canada· Recruiting
Lakeridge Health Oshawa
Verified postcode
Oshawa, Canada· Recruiting
Scarborough Centenary Hospital
Verified postcode
Toronto, Canada· Recruiting
Scarborough General Hospital
Verified postcode
Toronto, Canada· Recruiting
Scarborough Birchmount Hospital
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is the main purpose of this study?

The study wants to find out if aiming for slightly higher or lower magnesium levels helps critically ill patients survive longer and have fewer irregular heartbeats.

Will I have to do anything differently if I join?

No, you won't have any extra tasks, tests, or appointments. Your medical care will continue as normal in the intensive care unit.

Are there any extra risks if I participate?

There are no expected extra risks, as both ways of managing magnesium levels tested in the study are already considered safe and standard medical care.

Who can join this study?

You need to be at least 16 years old, in an intensive care unit, and your doctors need to have decided you require magnesium treatment.

Can I decide not to be in the study?

Yes, you or your family can decide not to participate at any time, and this will not affect your medical care in any way.

How to find out more

Joshua Craig

jcraig@shn.ca 4164382911 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.